215. Tetralogy of Fallot Clinical trials / Disease details
Clinical trials : 22 / Drugs : 48 - (DrugBank : 19) / Drug target genes : 18 - Drug target pathways : 49
| 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 | NCT04713657 (ClinicalTrials.gov) | March 30, 2022 | 13/1/2021 | Beta-blocker Administration for Cardiomyocyte Division | Mechanistic Clinical Trial of Beta-Blocker Administration For Reactivating Cardiomyocyte Division In Tetrology of Fallot | Tetralogy of Fallot | Other: N-thymidine;Other: Urine Collection;Procedure: Echocardiogram;Procedure: Cardiac MRI;Drug: Propranolol Hydrochloride;Drug: Placebo;Procedure: Physical Exam;Other: Specimen Collection | Bernhard Kuhn | University of Pittsburgh | Not yet recruiting | N/A | 2 Months | All | 40 | Phase 1 | United States |
| 2 | NCT05186415 (ClinicalTrials.gov) | January 2022 | 20/12/2021 | Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Tetralogy of Fallot | Contrast Enhanced Three Dimensional Echocardiographic Quantification of Right Ventricular Volumes in Repaired Tetralogy of Fallot | Tetralogy of Fallot | Drug: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Injection Powder for Suspension [LUMASON] | Nemours Children's Health System | Thomas Jefferson University | Not yet recruiting | 11 Years | N/A | All | 60 | Phase 1/Phase 2 | NULL |
| 3 | NCT05176782 (ClinicalTrials.gov) | December 15, 2021 | 15/12/2021 | Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair | Randomized Clinical Trial: Comparison Between Histidine-tryptophan-ketoglutarate Cardioplegia and Cold Blood Cardioplegia for Myocardial Protection for Fallot Tetralogy Patients Undergoing Total Repair | Anesthesia | Drug: HTK cardioplegia;Drug: Cold Cadioplegia | Ain Shams University | NULL | Recruiting | 6 Months | 5 Years | All | 52 | Early Phase 1 | Egypt |
| 4 | ChiCTR2000033234 | 2020-06-05 | 2020-05-25 | Comprehensive study for surgical effect and prognosis of Tetralogy of Fallot | A single-center ambispective cohort study for surgical effect and prognostic factors of Tetralogy of Fallot after surgical repair | Tetralogy of Fallot | TOF AS:annlus-sparing repair;TOF TAPE:transannular patch enlargement; | Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College | NULL | Pending | Both | TOF AS:247;TOF TAPE:247; | N/A | China | ||
| 5 | NCT04017975 (ClinicalTrials.gov) | December 20, 2019 | 10/7/2019 | Optical Tissue Identification for Myocardial Architecture | Optical Tissue Identification for Myocardial Architecture (OPTIMA Study) | Ventricular Septal Defect;Complete Atrioventricular Canal;Tetralogy of Fallot With Pulmonary Stenosis | Drug: Fluorescite;Device: Cellvizio 100 Series System with Confocal Miniprobes | Aditya Kaza | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | N/A | 18 Years | All | 70 | Phase 2 | United States |
| 6 | ChiCTR1900025513 | 2019-09-01 | 2019-08-31 | The safety and efficacy of preoperative oral supplementation of coenzyme Q10 in improving postoperative cardiac function in children with tetralogy of fallot (pulmonary atresia): a preliminary study | The safety and efficacy of preoperative oral supplementation of coenzyme Q10 in improving postoperative cardiac function in children with tetralogy of fallot (pulmonary atresia): a preliminary study | tetralogy of fallot (pulmonary atresia) | 01:N/A ;02:Oral coenzyme Q10, 2.5mg, t.i.d.;03:Oral coenzyme Q10, 5mg, t.i.d.;04:Oral coenzyme Q10, 10mg, t.i.d.;05:Oral coenzyme Q10, 20mg, t.i.d.; | Fuwai Central China Cardiovascualr Hospital | NULL | Pending | 0 | 2 | Both | 01:8;02:8;03:8;04:8;05:8; | China | |
| 7 | ChiCTR1800019578 | 2018-12-01 | 2018-11-18 | Effects of different tranexamic acid regimen in cyanotic pediatric cardiac surgery | Effects of different tranexamic acid regimen in cyanotic pediatric cardiac surgery | Tetralogy of Fallot | Conventional treatment group:Childen did not receive an antifibrinolytic agent during surgery;Low dose of tranexamic acid group:Loading dose: 10mg/kg (infant), 5mg/kg (children); Infusion: 2mg/kg.h; CPB prime dose: 20ug/mL of prime volume;High dose of tranexamic acid group:Loading dose: 30mg/kg (infant), 15mg/kg (children); Infusion: 6mg/kg.h; CPB prime dose: 60ug/mL of prime volume; | National Center for Cardiovascular Diseases, Fuwai Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | NULL | Pending | Both | Conventional treatment group:225;Low dose of tranexamic acid group:225;High dose of tranexamic acid group:225; | China | |||
| 8 | NCT03835494 (ClinicalTrials.gov) | November 1, 2018 | 8/1/2019 | Analysis of RV-Dysfunction in Fallot Patients | Tissue Doppler Imaging - A Promising Technique To Assess Myocardial Function In Adult Fallot Patients | Tetralogy of Fallot | Other: Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings. | Klinik für Kardiologie, Pneumologie und Angiologie | NULL | Completed | 18 Years | 80 Years | All | 60 | N/A | Germany |
| 9 | NCT03732742 (ClinicalTrials.gov) | November 2018 | 22/10/2018 | Comparison of Mid-term Results of Total Correction of TOF Between Preservation of PV and Trans-annular Patch. | Comparison of Mid-term Results of Total Correction of Tetralogy of Fallot Between Preservation of Pulmonary Valve and Trans-annular Patching | Tetrology of Fallot | Procedure: TOF repair with trans-annular patch VS preservation of PV | Assiut University | NULL | Unknown status | N/A | N/A | All | 50 | N/A | NULL |
| 10 | NCT03049995 (ClinicalTrials.gov) | November 2016 | 2/2/2017 | Stress Echo 2020 - The International Stress Echo Study | The International Stress Echo Study in Ischemic and Non-ischemic Heart Disease | Coronary Artery Disease;Heart Failure;Hypertrophic Cardiomyopathy;Aortic Valve Disease;Athletes Heart;Tetralogy of Fallot;Pulmonary Arterial Hypertension | Procedure: Left ventricular contractile reserve SE;Procedure: B-lines SE;Procedure: Left ventricular outflow tract gradient SE;Procedure: Diastolic function SE;Procedure: Mitral regurgitation SE;Procedure: Pulmonary hemodynamics SE;Procedure: Coronary flow reserve SE | Fatebenefratelli Hospital | Institute of Clinical Physiology, CNR, Pisa,Italy;Salerno Hospital, Italy;Monaldi Hospital, Napoli, Italy;University of Pisa, Italy;San Luca Hospital, Lucca, Italy;Careggi University Hospital, Florence, Italy;Federico II University;San Carlo Public Hospital, Potenza, Italy;Royal Brompton & Harefield NHS Foundation Trust;Ospedale dell'Angelo, Venezia-Mestre;University of Parma;Hospital Clinics, Trieste, Italy;Federal University of Rio Grande do Sul;Hospital San José, Criciuma, Brasil;Hospital San Vicente de Paulo, Passo Fundo, Brasil;University of Belgrade;University of Szeged, Hungary;Elisabeth Hospital, Hodmezovasarhely, Hungary;Sandro Pertini Hospital, Rome, Italy;Hospital Clinics, Bari, Italy;Ospedale Nottola, Siena, Italy;University of Catania, Italy;Medika Cardiocenter, Saint Petersburg, Russian Federation;Acibadem City Clinic Tokuda Hospital;Investigaciones Medicas, Buenos Aires, Argentina;Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian Federation;Instituto Nacional de Cardiología Mexico City, Mexico;Hamad Medical Corporation, Heart Hospital -Doha-Qatar | Recruiting | 18 Years | 85 Years | All | 300 | Italy | |
| 11 | ChiCTR-IOR-16008571 | 2016-06-06 | 2016-05-31 | Premedication for children with Tetralogy of Fallot | A comparative evalution of varies premedication regimes on children with Tetralogy of Fallot | Tetralogy of Fallot | oral dexmedetomidine:oral dexmedetomidine;oral ketamine:oral ketamine;oral dexmedetomidine mixed with ketamine:oral dexmedetomidine mixed with ketamine; | Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University | NULL | Recruiting | Both | oral dexmedetomidine:20;oral ketamine:20;oral dexmedetomidine mixed with ketamine:20; | China | |||
| 12 | EUCTR2013-002091-41-NL (EUCTR) | 09/10/2014 | 05/11/2013 | Research into the effect of the drug losartan in adult patients with a reduced function of the right cardiac chamber and a cardiac birth defect | Right vEntricular Dysfunction in tEtralogy of Fallot: INhibition of the rEnin-angiotensin-aldosterone system - Redefine trial | To study the effect of losartan in adult patients with Tetralogy of Fallot and right ventricular dysfunction, defined as right ventricular ejection fraction <50%. Without severe valvular lesions.;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | Trade Name: Losartan Product Name: Losartan INN or Proposed INN: Losartan Potassium Other descriptive name: LOSARTAN POTASSIUM | Academisch medisch centrum | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 13 | NCT01915277 (ClinicalTrials.gov) | April 2, 2014 | 30/7/2013 | A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics | A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics | Transposition of the Great Arteries;Tetralogy of Fallot;Ventricular Septal Defect | Drug: Dexmedetomidine | HealthCore-NERI | National Heart, Lung, and Blood Institute (NHLBI) | Completed | N/A | 180 Days | All | 119 | Phase 1 | United States |
| 14 | NCT02010905 (ClinicalTrials.gov) | December 2013 | 6/12/2013 | Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System | Right Ventricular Dysfunction in Tetralogy of Fallot: Inhibition of the Renin-angiotensin-aldosterone System | Tetralogy of Fallot;Heart Defects, Congenital;Ventricular Dysfunction, Right | Drug: Losartan;Drug: Placebo | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | The Interuniversity Cardiology Institute of the Netherlands | Recruiting | 18 Years | 80 Years | Both | 120 | Phase 2 | Netherlands |
| 15 | NCT01941576 (ClinicalTrials.gov) | September 1, 2013 | 3/9/2013 | Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot | Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot | Congenital Heart Defects;Tetralogy Of Fallot | Drug: recombinant human brain natriuretic peptide (rhBNP);Drug: Placebo (0.9% sodium chloride) | Shanghai Jiao Tong University School of Medicine | NULL | Completed | 1 Month | 18 Years | All | 120 | N/A | China |
| 16 | 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 |
| 17 | NCT00848393 (ClinicalTrials.gov) | November 2008 | 19/2/2009 | Measures to Lower the Stress Response in Pediatric Cardiac Surgery | Stress Response in Children Undergoing Cardiac Surgery: a Prospective Randomized Comparison Between Low Dose Fentanyl (LDF), Low Dose Fentanyl Plus Dexmedetomidine (LDF + Dex) and High Dose Fentanyl (HDF). | Tetralogy of Fallot (TOF);Ventricular Septal Defects (VSD);Atrioventricular Septal Defects (AVSD) | Drug: Fentanyl (High Dose);Drug: Fentanyl (Low Dose);Drug: Fentanyl (Low Dose) + Dexmedetomidine | Nationwide Children's Hospital | NULL | Completed | 1 Month | 3 Years | All | 52 | Phase 2 | United States |
| 18 | EUCTR2007-003461-41-DE (EUCTR) | 13/11/2007 | 10/09/2007 | Cardiac imaging under dobutamine stress for early assessment of right ventricular function in patients with tetralogy of Fallot and pulmonary regurgitation - Fallot-stress | Cardiac imaging under dobutamine stress for early assessment of right ventricular function in patients with tetralogy of Fallot and pulmonary regurgitation - Fallot-stress | Fallot tetralogy late after repair with marked pulmonary valve incompetence | INN or Proposed INN: Dobutamine | Deutsche Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler | NULL | Not Recruiting | Female: yes Male: yes | 80 | Germany | |||
| 19 | NCT00564993 (ClinicalTrials.gov) | November 2007 | 28/11/2007 | Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot | Cardiac Imaging Under Exercise Stress Test for Early Assessment of Right Ventricular Function in Patients With Tetralogy of Fallot and Pulmonary Regurgitation | Tetralogy of Fallot | Drug: Dobutamin | Competence Network for Congenital Heart Defects | German Federal Ministry of Education and Research | Terminated | 14 Years | N/A | Both | 53 | Phase 3 | Germany |
| 20 | NCT00557934 (ClinicalTrials.gov) | October 2007 | 13/11/2007 | Right Ventricular Contractility Reserve Following Repair of Tetralogy of Fallot | Evaluation of Right Ventricular Contractility Reserve Function During Dobutamine Stress in Patients Following Surgical Repair of Tetralogy of Fallot | Right Ventricular Dysfunction | Other: dobutamine | University Hospital Tuebingen | Fördergemeinschaft Deutsche Kinderherzzentren, Bonn, Germany | Completed | 4 Years | N/A | Both | 16 | N/A | Germany |
| 21 | NCT00573066 (ClinicalTrials.gov) | May 2004 | 11/12/2007 | Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery | The Pharmacokinetics, Pharmacogenetics, and Pharmacodynamics of Dexmedetomidine In Infants Post-Operative From Cardiac Surgery | Hypoplastic Left Heart;Tetralogy of Fallot;Tricuspid Atresia | Drug: Dexmedetomidine | Athena Zuppa | NULL | Completed | 1 Month | 24 Months | All | 56 | Phase 1 | NULL |
| 22 | NCT00004361 (ClinicalTrials.gov) | July 1995 | 18/10/1999 | Study of the Relationship Between Calcium Levels and Intact Parathyroid Hormone (iPTH) in Adults With Repaired or Palliated Conotruncal Cardiac Defects | Hypoparathyroidism;Tetralogy of Fallot;Pulmonary Valve Stenosis;Conotruncal Cardiac Defects;Heart Defects, Congenital;Pulmonary Atresia | Drug: calcium gluconate;Drug: sodium citrate | National Center for Research Resources (NCRR) | Ann & Robert H Lurie Children's Hospital of Chicago | Completed | 18 Years | N/A | Both | 150 | N/A | NULL |