210. Single ventricle heart defect
[
6 clinical trials,
7 drugs（DrugBank:
3 drugs),
3 target genes / 11 target pathways ]
Searched query = "Single ventricle heart defect", "Complete TGA", "Univentricular heart", "Single ventricular circulation syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/20/2019, 11/21/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03997097 | March 1, 2020 | 15 July 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 | Not recruiting | 15 Years | 80 Years | All | 50 | Phase 3 | ||
| 2 | EUCTR2018-002821-45-DE | 14 January 2019 | 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 Level: PT 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | Actelion Pharmaceuticals Ltd | Not Available | Female: yes Male: yes | 134 | Phase 3 | France;United States;Czech Republic;Taiwan;Poland;Ireland;Denmark;Australia;Germany;New Zealand;China;United Kingdom | ||||
| 3 | EUCTR2016-003320-23-DK | 25/08/2017 | 30 April 2019 | 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 Level: PT 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: MACITENTAN CAS Number: 441798-33-0 Current Sponsor code: ACT-064992 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 134 | Phase 3 | United Kingdom;China;New Zealand;Germany;Denmark;Australia;Ireland;Poland;Taiwan;Czech Republic;United States;France | |||
| 4 | EUCTR2010-022389-28-DK | 12/11/2010 | 12 May 2014 | 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 Pharmaceutical Form: Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Lars Søndergaard | Not Recruiting | Female: yes Male: yes | Denmark | |||||
| 5 | EUCTR2005-005898-29-GB | 04/07/2008 | 19 March 2012 | 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 Level: LLT Classification code 10065950 Term: Cavopulmonary anastomosis MedDRA version: 9.1 Level: LLT Classification code 10037456 Term: Pulmonary vascular resistance abnormality | Trade Name: Tracleer Product Name: bosentan Pharmaceutical Form: Tablet INN or Proposed INN: Bosentan CAS Number: 147536978 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- INN or Proposed INN: Bosentan CAS Number: 147536978 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- | University Hospital Birmingham | Authorised | Female: yes Male: yes | United Kingdom | |||||
| No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT00263406 | December 2002 | 19 February 2015 | 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 | Not recruiting | 1 Month | 18 Years | Both | 40 | Phase 2 | Belgium |