210. Single Ventricle Clinical trials / Disease details
Clinical trials : 49 / Drugs : 53 - (DrugBank : 23) / Drug target genes : 32 - Drug target pathways : 67
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03997097 (ClinicalTrials.gov) | June 1, 2022 | 18/6/2019 | Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease | Phosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III Study | Single-ventricle;Pulmonary Hypertension;Univentricular Heart | Drug: Sildenafil;Drug: Placebos | University Hospital, Montpellier | NULL | Not yet recruiting | 15 Years | 80 Years | All | 50 | Phase 3 | NULL |
| 2 | NCT04901975 (ClinicalTrials.gov) | February 11, 2021 | 14/5/2021 | Fibrosis and the Fontan | Acute Imposition of Fontan Physiology in The Single Ventricle Patient: Effects on Fibrosis, Function and Drug Intervention | Single-ventricle | Drug: Spironolactone | Children's Hospital of Philadelphia | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 1 Year | 6 Years | All | 120 | Phase 1/Phase 2 | United States |
| 3 | NCT04292483 (ClinicalTrials.gov) | June 11, 2020 | 29/2/2020 | Pulmonary Capillary Recruitment in Fontan Patients | Pulmonary Capillary Recruitment With Pulmonary Vasodilator Therapy in Patients With Univentricular Heart Physiology and Failing Total Cavo-pulmonary Connection. | Congenital Heart Disease | Drug: Nitric Oxide | Jewish General Hospital | National and Kapodistrian University of Athens;Tel Aviv University;Old Dominion University | Recruiting | 18 Years | 60 Years | All | 15 | Canada | |
| 4 | EUCTR2018-002821-45-CZ (EUCTR) | 29/04/2020 | 23/03/2020 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | ||
| 5 | NCT03877965 (ClinicalTrials.gov) | August 5, 2019 | 14/3/2019 | Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease | Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease | Congenital Heart Disease | Drug: Digoxin | Christoph P Hornik, MD MPH | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The Emmes Company, LLC | Active, not recruiting | N/A | 6 Months | All | 50 | United States | |
| 6 | EUCTR2018-002821-45-FR (EUCTR) | 05/03/2019 | 03/10/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | ||
| 7 | EUCTR2018-002821-45-DK (EUCTR) | 27/02/2019 | 02/01/2019 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Denmark;Australia;Germany;China;New Zealand | ||
| 8 | NCT03575572 (ClinicalTrials.gov) | August 29, 2018 | 18/6/2018 | Colchicine in Postoperative Fontan Patients | Colchicine in Postoperative Fontan Patients (CPFP) | Single-ventricle;Heart Diseases | Drug: Colchicine | University of Michigan | NULL | Terminated | 20 Months | 5 Years | All | 11 | Phase 2/Phase 3 | United States |
| 9 | NCT03430583 (ClinicalTrials.gov) | February 20, 2018 | 22/1/2018 | Evaluation of Fontan-Associated Liver Disease | Imaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal Study | Single Ventricle Heart Disease | Drug: MZ101 | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | 12 Years | N/A | All | 100 | United States;Canada | |
| 10 | NCT03079401 (ClinicalTrials.gov) | November 27, 2017 | 8/3/2017 | Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle | Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left Ventricle | Hypoplastic Left Heart Syndrome;Atrioventricular Canal | Biological: MPC; rexlemestrocel-L | Boston Children's Hospital | NULL | Active, not recruiting | N/A | 5 Years | All | 19 | Phase 1/Phase 2 | United States |
| 11 | NCT04035317 (ClinicalTrials.gov) | October 31, 2017 | 23/7/2019 | Aesculus Hippocastanum L. on Fontan Circulation | Effect of Aesculus Hippocastanum L. (Sapindaceae, Horse Chestnut) on Fontan Circulation - a Randomized Clinical Trial | Univentricular Heart | Drug: Aesculus Hippocastanum / Horse Chestnut;Drug: Placebo | Casa Espirita Terra de Ismael | Hospital das Clínicas de Ribeirão Preto | Withdrawn | 2 Years | 40 Years | All | 0 | Phase 2 | Brazil |
| 12 | EUCTR2016-003320-23-GB (EUCTR) | 11/10/2017 | 08/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 134 | Phase 3 | United Kingdom;China;New Zealand;Germany;Australia;Denmark;Ireland;Poland;Czech Republic;Taiwan;France;United States | ||
| 13 | EUCTR2016-003320-23-DE (EUCTR) | 12/09/2017 | 11/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | ||
| 14 | EUCTR2016-003320-23-DK (EUCTR) | 25/08/2017 | 19/05/2017 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | Poland;Denmark;Australia;Germany;China;New Zealand;Taiwan;Ireland;United Kingdom;France;Czech Republic;United States;Czechia | ||
| 15 | EUCTR2015-002610-76-NL (EUCTR) | 12/04/2017 | 12/10/2016 | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure | A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure | thromboprophylaxis MedDRA version: 20.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000011789;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Xarelto Product Code: JNJ-39039039; BAY 59-7939 INN or Proposed INN: RIVAROXABAN Trade Name: Aspirin Product Name: acetylsalicylic acid INN or Proposed INN: ACETYLSALICYLIC ACID | Janssen-Cilag International N.V | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of | ||
| 16 | NCT03088345 (ClinicalTrials.gov) | March 6, 2017 | 28/2/2017 | Early Use of Vasopressin in Post-Fontan Management | Use of Arginine Vasopressin in Early Postoperative Management After Fontan Palliation | Circulatory Perfusion Disorder;Congenital Heart Disease;Single-ventricle | Drug: Vasopressin, Arginine;Drug: Placebo | Medical College of Wisconsin | NULL | Completed | N/A | 18 Years | All | 20 | Phase 2/Phase 3 | United States |
| 17 | NCT03013751 (ClinicalTrials.gov) | January 2017 | 5/1/2017 | A Extension Study of Udenafil in Adolescents | A Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation | Functional Single Ventricle Heart Disease | Drug: Udenafil | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | 12 Years | 18 Years | All | 300 | Phase 3 | United States;Canada;Korea, Republic of |
| 18 | NCT02975999 (ClinicalTrials.gov) | December 2016 | 22/9/2016 | Use of Vasopressin Following the Fontan Operation | Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies | Pleural Effusion;Single-ventricle | Drug: Vasopressin;Drug: Normal Saline | Advocate Health Care | NULL | Suspended | 18 Months | 7 Years | All | 84 | Phase 2/Phase 3 | United States |
| 19 | NCT02946892 (ClinicalTrials.gov) | November 2016 | 23/9/2016 | Effect of Carvedilol on Exercise Performance in Fontan Patients | Effect of Carvedilol on Exercise Performance in Fontan Patients | Single Ventricle;Fontan | Drug: Carvedilol;Drug: Placebo | University of Texas Southwestern Medical Center | American Heart Association | Completed | 10 Years | 35 Years | All | 26 | Phase 4 | United States |
| 20 | EUCTR2015-002610-76-BE (EUCTR) | 21/09/2016 | 18/07/2016 | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure | A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure | thromboprophylaxis MedDRA version: 19.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Xarelto Product Code: JNJ-39039039; BAY 59-7939 INN or Proposed INN: RIVAROXABAN Trade Name: Aspirin Product Name: acetylsalicylic acid INN or Proposed INN: ACETYLSALICYLIC ACID | Janssen-Cilag International N.V | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of | ||
| 21 | EUCTR2015-002610-76-ES (EUCTR) | 19/09/2016 | 05/08/2016 | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure | A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure | Thromboprophylaxis MedDRA version: 19.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Xarelto Product Code: JNJ-39039039; BAY 59-7939 INN or Proposed INN: RIVAROXABAN Trade Name: Aspirin Product Name: acetylsalicylic acid INN or Proposed INN: ACETYLSALICYLIC ACID | Janssen-Cilag International N.V | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of | ||
| 22 | NCT02741115 (ClinicalTrials.gov) | July 22, 2016 | 10/4/2016 | Fontan Udenafil Exercise Longitudinal Assessment Trial | Fontan Udenafil Exercise Longitudinal Assessment Trial (FUEL) | Single Ventricle Heart Disease | Drug: Udenafil;Drug: Placebo | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 12 Years | 18 Years | All | 400 | Phase 3 | United States;Canada;Korea, Republic of |
| 23 | NCT02860702 (ClinicalTrials.gov) | July 2016 | 28/7/2016 | Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology | A Randomized Controlled Trial to Evaluate Growth Velocity and Clinical Outcomes of Infants With Single Ventricle Physiology Fed an Exclusive Human Milk Diet With Early Nutritional Fortification Following Surgical Repair | Congenital Heart Defect | Other: Human Milk Derived Fortifier;Other: Human/Bovine Milk | The University of Texas Health Science Center at San Antonio | Prolacta Bioscience;Baylor College of Medicine;Children's Hospital Medical Center, Cincinnati;Columbia University;University of Oklahoma;Ann & Robert H Lurie Children's Hospital of Chicago;Cook Children's Medical Center;Children's Hospital of Orange County;University of Texas;University of Florida | Active, not recruiting | N/A | 7 Days | All | 16 | N/A | United States |
| 24 | NCT02498444 (ClinicalTrials.gov) | September 2015 | 13/7/2015 | Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation | Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation | Single Ventricle | Drug: Treprostinil | Stanford University | NULL | Completed | 1 Year | 18 Years | All | 51 | N/A | United States |
| 25 | NCT02080637 (ClinicalTrials.gov) | July 2015 | 21/2/2014 | Ambrisentan in Single Ventricle | Safety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric Patients | Hypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart Complex | Drug: Ambrisentan;Other: Placebo | Kevin Hill | NULL | Completed | 24 Months | 120 Months | All | 16 | Phase 2 | United States |
| 26 | NCT02201342 (ClinicalTrials.gov) | July 2014 | 24/7/2014 | Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents | A Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan Palliation | Single Ventricle Heart Disease After Fontan Surgery | Drug: Udenafil | Mezzion Pharma Co. Ltd | National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network;National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network | Completed | 14 Years | 18 Years | Both | 36 | Phase 1/Phase 2 | United States;Canada |
| 27 | NCT01971593 (ClinicalTrials.gov) | August 2013 | 23/10/2013 | The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart Disease | Eplerenone to Prevent Myocardial Fibrosis in Congenital Heart Disease | Tetralogy of Fallot;Transposition of the Great Vessels With an Arterial Switch;Single Ventricle With a Fontan Palliation | Drug: Eplerenone | Washington University School of Medicine | Pfizer | Terminated | 18 Years | 80 Years | All | 26 | Phase 4 | United States |
| 28 | NCT01971580 (ClinicalTrials.gov) | August 2012 | 23/10/2013 | The Effects of Ambrisentan on Exercise Capacity in Fontan Patients | The Effects of Ambrisentan on Exercise Capacity in Fontan Patients | Single Ventricle Fontan Palliation | Drug: Ambrisentan | Washington University School of Medicine | NULL | Completed | 18 Years | 50 Years | All | 28 | Phase 4 | United States |
| 29 | EUCTR2011-001187-21-DE (EUCTR) | 28/11/2011 | 30/05/2011 | Pilot study with children suffering from congenital heart defect who need a vascular surgery: Implantation of a living blood vessel that is produced in the laboratory from child's own body tissue. | A Phase I/II, Open Monocentric Study To Evaluate The Safety And Efficacy Of An Autologous Tissue-Engineered Vascular Graft In Peadiatric Patients Requiring Reconstruction Of Right Ventricle Outflow Tract. - SCRM-001 TEVG Study | functional single ventricle physiologyfunctional single left ventriclefunctional single right ventriclefunctional single biventricle MedDRA version: 14.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Autologous Tissue-Engineered Vascular Graft Product Code: SCRM001_TEVG | University of Zurich | NULL | Not Recruiting | Female: yes Male: yes | Phase 1/2 | Germany | |||
| 30 | NCT01291069 (ClinicalTrials.gov) | September 2011 | 4/2/2011 | Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients | Effect of Tadalafil on Exercise Capacity in Pediatric Fontan Patients | Single Ventricle | Drug: Tadalafil Citrate;Drug: Sugar pill | University of Utah | NULL | Completed | 8 Years | 35 Years | All | 20 | Phase 1 | United States |
| 31 | NCT01169519 (ClinicalTrials.gov) | April 2011 | 7/7/2010 | Sildenafil in Single Ventricle Patients | Safety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle Patients | Heart Disease | Drug: Sildenafil by injection | Duke University | NULL | Completed | 3 Months | 120 Months | All | 21 | Phase 1 | United States |
| 32 | NCT01292551 (ClinicalTrials.gov) | February 2011 | 8/2/2011 | Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology. | Treatment With Endothelin Antagonist to Tcpc Patients; a Multicenter, Randomized, Prospective Study Measuring Maximal O2 Uptake in Ergometer Bicycle Test | Hypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of Heart | Drug: Bosentan;Drug: Placebo | Rigshospitalet, Denmark | Aarhus University Hospital;Bispebjerg Hospital;Actelion | Completed | 15 Years | N/A | Both | 75 | Phase 2 | Denmark;Sweden |
| 33 | JPRN-UMIN000005343 | 2011/01/01 | 01/04/2011 | Effect of sildenafil in patients with single ventricle physiology | Single ventricle physiology | Administration of sildenafil | Tokyo Women's Medical University | NULL | Recruiting | 3months-old | Not applicable | Male and Female | 30 | Not applicable | Japan | |
| 34 | EUCTR2010-022389-28-DK (EUCTR) | 12/11/2010 | 26/10/2010 | Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test.[TEMPO-study]. | Treatment with Endothelinantagonist to tcpc patients; a multicenter, randomized, Prospective study measuring maximal O2 uptake in ergometer bicycle test.[TEMPO-study]. | Patients with a univentricular heart, who have recieved paliating surgery in the form of TCPC operation MedDRA version: 14.1;Level: PT;Classification code 10021076;Term: Hypoplastic left heart syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Tracleer | Lars Søndergaard | NULL | Not Recruiting | Female: yes Male: yes | Denmark | ||||
| 35 | NCT01161641 (ClinicalTrials.gov) | July 2010 | 9/7/2010 | Pilot/Ph I Safety and Efficacy of ODSH in Protein Losing Enteropathy Secondary to Single Ventricle Palliative Surgery | An Open Label Pilot Study Evaluating Safety and Evidence of Therapeutic Effect of IV Admin of 2-0, 3-0 Desulfated Heparin, Treatment of Exacerbation of Protein Losing Enteropathy (PLE) Associated With Single Ventricle Palliative Surgery | Protein Losing Enteropathy | Drug: ODSH at 0.125 mg/kg/h;Drug: ODSH at 0.375 mg/kg/h;Drug: ODSH at 0.250 mg/kg/h | Chimerix | NULL | Terminated | 6 Years | N/A | All | 5 | Phase 1 | United States |
| 36 | NCT00989911 (ClinicalTrials.gov) | May 2010 | 5/10/2009 | Endothelin Blockade in Patients With Single Ventricle Physiology | Endothelin Blockade in Patients With Single Ventricle Physiology | Congenital Heart Disease | Drug: Bosentan | University of California, Los Angeles | Actelion | Completed | 12 Years | N/A | All | 10 | N/A | United States |
| 37 | NCT01662037 (ClinicalTrials.gov) | January 2010 | 5/8/2012 | Bosentan Therapy in Children With Functional Single Ventricle | Bosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single Ventricle | Congenital Heart Defects;Functional Single Ventricle | Drug: Bosentan | Shanghai Jiao Tong University School of Medicine | NULL | Completed | 4 Months | 18 Years | Both | 34 | Phase 2 | China |
| 38 | NCT00974025 (ClinicalTrials.gov) | June 2009 | 9/9/2009 | Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated Patients | Vitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan Palliation | Fontan Procedure;Hypoplastic Left Heart Syndrome;Tricuspid Atresia | Dietary Supplement: Vitamin C;Dietary Supplement: Placebo | University of Michigan | Griese-Hutchinson Champions for Children's Hearts Investigator Award | Completed | 8 Years | 25 Years | All | 53 | N/A | United States |
| 39 | EUCTR2005-005898-29-GB (EUCTR) | 04/07/2008 | 09/05/2008 | The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans | The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in Fontans | Patients with a Fontan circulation (that is they have had a Fontan operation for a functionally univentricular heart) MedDRA version: 9.1;Level: LLT;Classification code 10045545;Term: Univentricular heart MedDRA version: 9.1;Classification code 10065950;Term: Cavopulmonary anastomosis MedDRA version: 9.1;Classification code 10037456;Term: Pulmonary vascular resistance abnormality | Trade Name: Tracleer Product Name: bosentan INN or Proposed INN: Bosentan INN or Proposed INN: Bosentan | University Hospital Birmingham | NULL | Not Recruiting | Female: yes Male: yes | 15 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 40 | NCT00211081 (ClinicalTrials.gov) | November 2004 | 13/9/2005 | Spironolactone in Patients With Single Ventricle Heart | Impact of Spironolactone on Endothelial Function in Patients With Single Ventricle Heart | Congenital Disorders | Drug: Spironolactone (drug) | Emory University | NULL | Completed | 18 Years | N/A | All | 12 | N/A | United States |
| 41 | NCT00113087 (ClinicalTrials.gov) | August 2003 | 3/6/2005 | Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network | Trial of ACE Inhibition in Infants With Single Ventricle (A Trial Conducted by the Pediatric Heart Network) | Heart Defects, Congenital;Heart Failure, Congestive | Drug: Enalapril;Drug: Placebo | National Heart, Lung, and Blood Institute (NHLBI) | Pediatric Heart Network | Completed | N/A | 45 Days | All | 230 | Phase 3 | United States;Canada |
| 42 | NCT00263406 (ClinicalTrials.gov) | December 2002 | 4/12/2005 | Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation | Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation | Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation | Drug: Administration of an ACE-inhibitor or not | University Hospital, Ghent | NULL | Completed | 1 Month | 18 Years | Both | 40 | Phase 2 | Belgium |
| 43 | NCT00004828 (ClinicalTrials.gov) | December 1994 | 24/2/2000 | Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan Procedure | Tricuspid Atresia;Heart Defects, Congenital | Drug: liothyronine I 131 | FDA Office of Orphan Products Development | Children's Hospital and Health Center | Completed | N/A | 17 Years | Both | 28 | Phase 1 | NULL | |
| 44 | EUCTR2018-002821-45-GB (EUCTR) | 28/12/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 134 | Phase 3 | United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand | |||
| 45 | EUCTR2018-002821-45-PL (EUCTR) | 19/09/2019 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | AC-055H302, RUBATO OL, Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | NA | Female: yes Male: yes | 134 | Phase 3 | New Zealand;China;Germany;Denmark;Australia;Poland;Czech Republic;France;United Kingdom;Ireland;Taiwan;Czechia;United States | |||
| 46 | EUCTR2015-002610-76-FR (EUCTR) | 01/08/2016 | A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure | A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure - UNIVERSE | thromboprophylaxis MedDRA version: 20.0;Level: LLT;Classification code 10040729;Term: Single ventricle;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Xarelto Product Code: JNJ-39039039; BAY 59-7939 INN or Proposed INN: RIVAROXABAN Trade Name: Aspirin Product Name: acetylsalicylic acid INN or Proposed INN: ACETYLSALICYLIC ACID | Janssen-Cilag International N.V | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of | |||
| 47 | EUCTR2018-002821-45-DE (EUCTR) | 27/12/2018 | An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patients | Prospective, multi-center, single-arm, open-label long-term study assessing the safety, tolerability, and effectiveness of macitentan in Fontan-palliated adult and adolescent subjects - RUBATO OL | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China | |||
| 48 | EUCTR2018-004828-11-FR (EUCTR) | 29/03/2019 | Phosphodiesterase-type 5 inhibitors in adult and adolescent patients with univentricular heart disease: a multi-center, randomized, double blind phase III study | Phosphodiesterase-type 5 inhibitors in adult and adolescent patients with univentricular heart disease: a multi-center, randomized, double blind phase III study - VU-Inhibition | adult and adolescent patients with univentricular heart diseases and pulmonary arterial pressure;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Product Name: Mysildecard | University Hospital of Montpellier | NULL | NA | Female: yes Male: yes | 50 | Phase 3 | France | |||
| 49 | EUCTR2016-003320-23-PL (EUCTR) | 18/09/2018 | Clinical study assessing the safety and efficacy of macitentan in Fontan-palliated subjects. | Prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group study assessing the efficacy and safety of macitentan in Fontan-palliated adult and adolescent subjects. - RUBATO | Congenital Heart Failure MedDRA version: 20.0;Level: PT;Classification code 10045545;Term: Univentricular heart;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.1;Classification code 10065950;Term: Cavopulmonary anastomosis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] | Trade Name: Opsumit® Product Name: macitentan Product Code: ACT-064992 INN or Proposed INN: MACITENTAN | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 134 | Phase 3 | United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand |