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	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
2	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
3	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
4	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

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

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

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

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

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

Phase 2

United States

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

Phase 1

NULL