DDrare: Database of Drug Development for Rare Diseases

Searched query = "Tetralogy of Fallot", "Fallot tetralogy"
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 = AS; CPX; Calcium; Calcium gluconate; Coenzyme Q10; Device: Cellvizio 100 Series System with Confocal Miniprobes; Dexmedetomidine; Dobutamin; Dobutamine; Eplerenone; Fentanyl; Fentanyl (High Dose); Fentanyl (Low Dose); Fentanyl (Low Dose) + Dexmedetomidine; Fluorescite; Gradient; Ketamine; LOSARTAN POTASSIUM; Losartan; Losartan Potassium; 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.; Other: dobutamine; PV; Potassium; Procedure: B-lines SE; Procedure: Coronary flow reserve SE; Procedure: Diastolic function SE; Procedure: Left ventricular contractile reserve SE; Procedure: Left ventricular outflow tract gradient SE; Procedure: Mitral regurgitation SE; Procedure: Pulmonary hemodynamics SE; Procedure: TOF repair with trans-annular patch VS preservation of PV; Recombinant human brain natriuretic peptide (rhBNP); Sodium citrate; Tranexamic acid

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	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
2	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

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

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

NCT02010905
(ClinicalTrials.gov)

December 2013

6/12/2013

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