DDrare: Database of Drug Development for Rare Diseases

Searched query = "Single Ventricle", "SV", "Single ventricle heart defect", "Univentricular heart", "UVH", "Single ventricular circulation syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = ACETYLSALICYLIC ACID; ACT-064992; Acetylsalicylic acid; Administration of an ACE-inhibitor or not; Aesculus Hippocastanum / Horse Chestnut; Ambrisentan; Arginine; Aspirin; Autologous Tissue-Engineered Vascular Graft; BAY 59-7939; Bosentan; Carvedilol; Colchicine; Digoxin; Enalapril; Eplerenone; Horse chestnut; JNJ-39039039; Liothyronine; Liothyronine I 131; MACITENTAN; MPC; MZ101; Macitentan; Milk; Mysildecard; Mysildecard 20 mg; Nitric Oxide; Normal Saline; ODSH at 0.125 mg/kg/h; ODSH at 0.250 mg/kg/h; ODSH at 0.375 mg/kg/h; Opsumit; Opsumit®; Other: Human Milk Derived Fortifier; Other: Human/Bovine Milk; RIVAROXABAN; Rexlemestrocel-L; Rivaroxaban; SCRM001_TEVG; Sildenafil; Sildenafil by injection; Spironolactone; Spironolactone (drug); Sugar pill; Tadalafil; Tadalafil Citrate; Tracleer; Treprostinil; Udenafil; Vasopressin; Vasopressin, Arginine; Vitamin C; Xarelto

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	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
2	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
3	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
4	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		University Hospital Birmingham	NULL	Not Recruiting			Female: yes Male: yes	15	Phase 4	United Kingdom

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

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

Phase 2

Denmark;Sweden

NCT00989911
(ClinicalTrials.gov)

May 2010

5/10/2009

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

N/A

United States

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

Phase 2

China

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

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

University Hospital Birmingham

NULL

Not Recruiting

Female: yes
Male: yes

Phase 4

United Kingdom