210. 単心室症 Single Ventricle Clinical trials / Disease details


臨床試験数 : 49 薬物数 : 53 - (DrugBank : 23) / 標的遺伝子数 : 32 - 標的パスウェイ数 : 67

  
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
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Inclusion_
gender
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PhaseCountries
1NCT03997097
(ClinicalTrials.gov)
June 1, 202218/6/2019Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart DiseasePhosphodiesterase-type 5 Inhibitors in Adult and Adolescent Patients With Univentricular Heart Disease: a Multi-center, Randomized, Double Blind Phase III StudySingle-ventricle;Pulmonary Hypertension;Univentricular HeartDrug: Sildenafil;Drug: PlacebosUniversity Hospital, MontpellierNULLNot yet recruiting15 Years80 YearsAll50Phase 3NULL
2NCT04901975
(ClinicalTrials.gov)
February 11, 202114/5/2021Fibrosis and the FontanAcute Imposition of Fontan Physiology in The Single Ventricle Patient: Effects on Fibrosis, Function and Drug InterventionSingle-ventricleDrug: SpironolactoneChildren's Hospital of PhiladelphiaNational Heart, Lung, and Blood Institute (NHLBI)Recruiting1 Year6 YearsAll120Phase 1/Phase 2United States
3NCT04292483
(ClinicalTrials.gov)
June 11, 202029/2/2020Pulmonary Capillary Recruitment in Fontan PatientsPulmonary Capillary Recruitment With Pulmonary Vasodilator Therapy in Patients With Univentricular Heart Physiology and Failing Total Cavo-pulmonary Connection.Congenital Heart DiseaseDrug: Nitric OxideJewish General HospitalNational and Kapodistrian University of Athens;Tel Aviv University;Old Dominion UniversityRecruiting18 Years60 YearsAll15Canada
4EUCTR2018-002821-45-CZ
(EUCTR)
29/04/202023/03/2020An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsAC-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 LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China
5NCT03877965
(ClinicalTrials.gov)
August 5, 201914/3/2019Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart DiseasePharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart DiseaseCongenital Heart DiseaseDrug: DigoxinChristoph P Hornik, MD MPHEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);The Emmes Company, LLCActive, not recruitingN/A6 MonthsAll50United States
6EUCTR2018-002821-45-FR
(EUCTR)
05/03/201903/10/2018An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsProspective, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China
7EUCTR2018-002821-45-DK
(EUCTR)
27/02/201902/01/2019An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsAC-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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134Phase 3United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Denmark;Australia;Germany;China;New Zealand
8NCT03575572
(ClinicalTrials.gov)
August 29, 201818/6/2018Colchicine in Postoperative Fontan PatientsColchicine in Postoperative Fontan Patients (CPFP)Single-ventricle;Heart DiseasesDrug: ColchicineUniversity of MichiganNULLTerminated20 Months5 YearsAll11Phase 2/Phase 3United States
9NCT03430583
(ClinicalTrials.gov)
February 20, 201822/1/2018Evaluation of Fontan-Associated Liver DiseaseImaging and Biomarker Evaluation of Hepatic Stiffness in Children Enrolled in the Fontan Udenafil Exercise Longitudinal StudySingle Ventricle Heart DiseaseDrug: MZ101Mezzion Pharma Co. LtdNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting12 YearsN/AAll100United States;Canada
10NCT03079401
(ClinicalTrials.gov)
November 27, 20178/3/2017Mesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left VentricleMesoblast Stem Cell Therapy for Patients With Single Ventricle and Borderline Left VentricleHypoplastic Left Heart Syndrome;Atrioventricular CanalBiological: MPC; rexlemestrocel-LBoston Children's HospitalNULLActive, not recruitingN/A5 YearsAll19Phase 1/Phase 2United States
11NCT04035317
(ClinicalTrials.gov)
October 31, 201723/7/2019Aesculus Hippocastanum L. on Fontan CirculationEffect of Aesculus Hippocastanum L. (Sapindaceae, Horse Chestnut) on Fontan Circulation - a Randomized Clinical TrialUniventricular HeartDrug: Aesculus Hippocastanum / Horse Chestnut;Drug: PlaceboCasa Espirita Terra de IsmaelHospital das Clínicas de Ribeirão PretoWithdrawn2 Years40 YearsAll0Phase 2Brazil
12EUCTR2016-003320-23-GB
(EUCTR)
11/10/201708/05/2017Clinical 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
134Phase 3United Kingdom;China;New Zealand;Germany;Australia;Denmark;Ireland;Poland;Czech Republic;Taiwan;France;United States
13EUCTR2016-003320-23-DE
(EUCTR)
12/09/201711/05/2017Clinical 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 LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China
14EUCTR2016-003320-23-DK
(EUCTR)
25/08/201719/05/2017Clinical 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 LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3Poland;Denmark;Australia;Germany;China;New Zealand;Taiwan;Ireland;United Kingdom;France;Czech Republic;United States;Czechia
15EUCTR2015-002610-76-NL
(EUCTR)
12/04/201712/10/2016A 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 ProcedureA 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.VNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of
16NCT03088345
(ClinicalTrials.gov)
March 6, 201728/2/2017Early Use of Vasopressin in Post-Fontan ManagementUse of Arginine Vasopressin in Early Postoperative Management After Fontan PalliationCirculatory Perfusion Disorder;Congenital Heart Disease;Single-ventricleDrug: Vasopressin, Arginine;Drug: PlaceboMedical College of WisconsinNULLCompletedN/A18 YearsAll20Phase 2/Phase 3United States
17NCT03013751
(ClinicalTrials.gov)
January 20175/1/2017A Extension Study of Udenafil in AdolescentsA Phase III Extension Study of Udenafil in Adolescents With Single Ventricle Physiology After Fontan PalliationFunctional Single Ventricle Heart DiseaseDrug: UdenafilMezzion Pharma Co. LtdNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting12 Years18 YearsAll300Phase 3United States;Canada;Korea, Republic of
18NCT02975999
(ClinicalTrials.gov)
December 201622/9/2016Use of Vasopressin Following the Fontan OperationUse of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter StudiesPleural Effusion;Single-ventricleDrug: Vasopressin;Drug: Normal SalineAdvocate Health CareNULLSuspended18 Months7 YearsAll84Phase 2/Phase 3United States
19NCT02946892
(ClinicalTrials.gov)
November 201623/9/2016Effect of Carvedilol on Exercise Performance in Fontan PatientsEffect of Carvedilol on Exercise Performance in Fontan PatientsSingle Ventricle;FontanDrug: Carvedilol;Drug: PlaceboUniversity of Texas Southwestern Medical CenterAmerican Heart AssociationCompleted10 Years35 YearsAll26Phase 4United States
20EUCTR2015-002610-76-BE
(EUCTR)
21/09/201618/07/2016A 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 ProcedureA 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.VNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Thailand;Spain;United Kingdom;France;Mexico;Canada;Argentina;Belgium;Brazil;Malaysia;Australia;Netherlands;China;Japan;Korea, Republic of
21EUCTR2015-002610-76-ES
(EUCTR)
19/09/201605/08/2016A 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 ProcedureA 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.VNULLNot 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): noUnited States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of
22NCT02741115
(ClinicalTrials.gov)
July 22, 201610/4/2016Fontan Udenafil Exercise Longitudinal Assessment TrialFontan Udenafil Exercise Longitudinal Assessment Trial (FUEL)Single Ventricle Heart DiseaseDrug: Udenafil;Drug: PlaceboMezzion Pharma Co. LtdNational Heart, Lung, and Blood Institute (NHLBI)Completed12 Years18 YearsAll400Phase 3United States;Canada;Korea, Republic of
23NCT02860702
(ClinicalTrials.gov)
July 201628/7/2016Exclusive Human Milk Feeding in Infants With Single Ventricle PhysiologyA 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 RepairCongenital Heart DefectOther: Human Milk Derived Fortifier;Other: Human/Bovine MilkThe University of Texas Health Science Center at San AntonioProlacta 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 FloridaActive, not recruitingN/A7 DaysAll16N/AUnited States
24NCT02498444
(ClinicalTrials.gov)
September 201513/7/2015Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan OperationPerioperative Treprostinil in Pediatric Patients Undergoing the Fontan OperationSingle VentricleDrug: TreprostinilStanford UniversityNULLCompleted1 Year18 YearsAll51N/AUnited States
25NCT02080637
(ClinicalTrials.gov)
July 201521/2/2014Ambrisentan in Single VentricleSafety, Pharmacokinetics (PK) and Hemodynamic Effects of Ambrisentan in Single Ventricle Pediatric PatientsHypoplastic Left Heart Syndrome;Hypoplastic Right-sided Heart ComplexDrug: Ambrisentan;Other: PlaceboKevin HillNULLCompleted24 Months120 MonthsAll16Phase 2United States
26NCT02201342
(ClinicalTrials.gov)
July 201424/7/2014Pharmacokinetic/Pharmacodynamic Study of Udenafil in AdolescentsA Phase I/II Dose Escalation Trial of Udenafil in Adolescents With Single Ventricle Physiology After Fontan PalliationSingle Ventricle Heart Disease After Fontan SurgeryDrug: UdenafilMezzion Pharma Co. LtdNational Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart Network;National Heart, Lung, and Blood Institute (NHLBI);Pediatric Heart NetworkCompleted14 Years18 YearsBoth36Phase 1/Phase 2United States;Canada
27NCT01971593
(ClinicalTrials.gov)
August 201323/10/2013The Effects of Eplerenone on Markers of Myocardial Fibrosis in Adult Congenital Heart DiseaseEplerenone to Prevent Myocardial Fibrosis in Congenital Heart DiseaseTetralogy of Fallot;Transposition of the Great Vessels With an Arterial Switch;Single Ventricle With a Fontan PalliationDrug: EplerenoneWashington University School of MedicinePfizerTerminated18 Years80 YearsAll26Phase 4United States
28NCT01971580
(ClinicalTrials.gov)
August 201223/10/2013The Effects of Ambrisentan on Exercise Capacity in Fontan PatientsThe Effects of Ambrisentan on Exercise Capacity in Fontan PatientsSingle Ventricle Fontan PalliationDrug: AmbrisentanWashington University School of MedicineNULLCompleted18 Years50 YearsAll28Phase 4United States
29EUCTR2011-001187-21-DE
(EUCTR)
28/11/201130/05/2011Pilot 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 ZurichNULLNot RecruitingFemale: yes
Male: yes
Phase 1/2Germany
30NCT01291069
(ClinicalTrials.gov)
September 20114/2/2011Effect of Tadalafil on Exercise Capacity in Pediatric Fontan PatientsEffect of Tadalafil on Exercise Capacity in Pediatric Fontan PatientsSingle VentricleDrug: Tadalafil Citrate;Drug: Sugar pillUniversity of UtahNULLCompleted8 Years35 YearsAll20Phase 1United States
31NCT01169519
(ClinicalTrials.gov)
April 20117/7/2010Sildenafil in Single Ventricle PatientsSafety, Pharmacokinetics and Hemodynamic Efficacy of Sildenafil in Single Ventricle PatientsHeart DiseaseDrug: Sildenafil by injectionDuke UniversityNULLCompleted3 Months120 MonthsAll21Phase 1United States
32NCT01292551
(ClinicalTrials.gov)
February 20118/2/2011Study 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 TestHypoplastic Left Heart Syndrome;Tricuspid Atresia;Other Specified Congenital Anomalies of HeartDrug: Bosentan;Drug: PlaceboRigshospitalet, DenmarkAarhus University Hospital;Bispebjerg Hospital;ActelionCompleted15 YearsN/ABoth75Phase 2Denmark;Sweden
33JPRN-UMIN000005343
2011/01/0101/04/2011Effect of sildenafil in patients with single ventricle physiology Single ventricle physiologyAdministration of sildenafilTokyo Women's Medical UniversityNULLRecruiting3months-oldNot applicableMale and Female30Not applicableJapan
34EUCTR2010-022389-28-DK
(EUCTR)
12/11/201026/10/2010Treatment 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: TracleerLars SøndergaardNULLNot RecruitingFemale: yes
Male: yes
Denmark
35NCT01161641
(ClinicalTrials.gov)
July 20109/7/2010Pilot/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 SurgeryProtein Losing EnteropathyDrug: ODSH at 0.125 mg/kg/h;Drug: ODSH at 0.375 mg/kg/h;Drug: ODSH at 0.250 mg/kg/hChimerixNULLTerminated6 YearsN/AAll5Phase 1United States
36NCT00989911
(ClinicalTrials.gov)
May 20105/10/2009Endothelin Blockade in Patients With Single Ventricle PhysiologyEndothelin Blockade in Patients With Single Ventricle PhysiologyCongenital Heart DiseaseDrug: BosentanUniversity of California, Los AngelesActelionCompleted12 YearsN/AAll10N/AUnited States
37NCT01662037
(ClinicalTrials.gov)
January 20105/8/2012Bosentan Therapy in Children With Functional Single VentricleBosentan Therapy for High Risk Staged Fontan Procedure in Children With Functional Single VentricleCongenital Heart Defects;Functional Single VentricleDrug: BosentanShanghai Jiao Tong University School of MedicineNULLCompleted4 Months18 YearsBoth34Phase 2China
38NCT00974025
(ClinicalTrials.gov)
June 20099/9/2009Impact of Vitamin C on Endothelial Function and Exercise Capacity in Fontan-Palliated PatientsVitamin C May Improve Endothelial Function and Exercise Capacity in Functional Single Ventricle Patients After Fontan PalliationFontan Procedure;Hypoplastic Left Heart Syndrome;Tricuspid AtresiaDietary Supplement: Vitamin C;Dietary Supplement: PlaceboUniversity of MichiganGriese-Hutchinson Champions for Children's Hearts Investigator AwardCompleted8 Years25 YearsAll53N/AUnited States
39EUCTR2005-005898-29-GB
(EUCTR)
04/07/200809/05/2008The effect of bosentan, a selective endothelin antagonist, on cardiovascular performance in patients with a Fontan circulation - Bosentan therapy in FontansThe 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 BirminghamNULLNot 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): yesUnited Kingdom
40NCT00211081
(ClinicalTrials.gov)
November 200413/9/2005Spironolactone in Patients With Single Ventricle HeartImpact of Spironolactone on Endothelial Function in Patients With Single Ventricle HeartCongenital DisordersDrug: Spironolactone (drug)Emory UniversityNULLCompleted18 YearsN/AAll12N/AUnited States
41NCT00113087
(ClinicalTrials.gov)
August 20033/6/2005Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart NetworkTrial of ACE Inhibition in Infants With Single Ventricle (A Trial Conducted by the Pediatric Heart Network)Heart Defects, Congenital;Heart Failure, CongestiveDrug: Enalapril;Drug: PlaceboNational Heart, Lung, and Blood Institute (NHLBI)Pediatric Heart NetworkCompletedN/A45 DaysAll230Phase 3United States;Canada
42NCT00263406
(ClinicalTrials.gov)
December 20024/12/2005Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan CirculationPathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan CirculationChildren With a Univentricular Heart Undergoing Surgery for Creation of a Fontan CirculationDrug: Administration of an ACE-inhibitor or notUniversity Hospital, GhentNULLCompleted1 Month18 YearsBoth40Phase 2Belgium
43NCT00004828
(ClinicalTrials.gov)
December 199424/2/2000Liothyronine in Children With Single Ventricle Congenital Cardiac Malformations Undergoing the Fontan ProcedureTricuspid Atresia;Heart Defects, CongenitalDrug: liothyronine I 131FDA Office of Orphan Products DevelopmentChildren's Hospital and Health CenterCompletedN/A17 YearsBoth28Phase 1NULL
44EUCTR2015-002610-76-FR
(EUCTR)
01/08/2016A 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 ProcedureA 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.VNULLNot 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): noUnited States;Spain;Thailand;United Kingdom;France;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Netherlands;China;Japan;Korea, Republic of
45EUCTR2018-002821-45-DE
(EUCTR)
27/12/2018An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsProspective, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;France;Taiwan;Czech Republic;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;New Zealand;China
46EUCTR2016-003320-23-PL
(EUCTR)
18/09/2018Clinical 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 LtdNULLNot RecruitingFemale: yes
Male: yes
134Phase 3United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand
47EUCTR2018-004828-11-FR
(EUCTR)
29/03/2019Phosphodiesterase-type 5 inhibitors in adult and adolescent patients with univentricular heart disease: a multi-center, randomized, double blind phase III studyPhosphodiesterase-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: MysildecardUniversity Hospital of MontpellierNULLNAFemale: yes
Male: yes
50Phase 3France
48EUCTR2018-002821-45-GB
(EUCTR)
28/12/2018An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsAC-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 LtdNULLNAFemale: yes
Male: yes
134Phase 3United States;Czechia;Taiwan;Ireland;United Kingdom;France;Czech Republic;Poland;Australia;Denmark;Germany;China;New Zealand
49EUCTR2018-002821-45-PL
(EUCTR)
19/09/2019An upcoming clinical study to measure the safety and impact of a drug called macitentan in teenage and adult Fontan patientsAC-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 LtdNULLNAFemale: yes
Male: yes
134Phase 3New Zealand;China;Germany;Denmark;Australia;Poland;Czech Republic;France;United Kingdom;Ireland;Taiwan;Czechia;United States