Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology

Sponsor

Mayo Clinic (Other)

Overall Status

Recruiting

CT.gov ID

NCT05206955

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Arms

59.1

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to find out more about the effectiveness of Tadalafil in improving hemodynamic capabilities, endothelial function, and end-organ function in patients who have previously undergone a Fontan Palliation.

Condition or Disease	Intervention/Treatment	Phase
Fontan Palliation	Drug: Tadalafil Drug: Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Tadalafil Versus Placebo in Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology (TRIUMPH Trial)

Actual Study Start Date :

Mar 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2027

Anticipated Study Completion Date :

Feb 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tadalafil Group Study participants will receive 10 mg of Tadalafil daily for 1 week, then 20 mg daily for 1 week, and finally 40 mg daily for 50 weeks for a total therapy time of 52 weeks. Tadalafil will be taken orally in capsule form once daily.	Drug: Tadalafil 10 mg once daily orally week 1, 20 mg once daily orally during week 2, and 40 mg once daily orally during weeks 3 through 52
Placebo Comparator: Placebo Group Study participants will receive a placebo capsule that looks identical to the Tadalafil capsule. The placebo will be taken orally once daily for 52 weeks.	Drug: Placebo Looks exactly like the study drug, but it contains no active ingredient

Arm

Intervention/Treatment

Experimental: Tadalafil Group

Study participants will receive 10 mg of Tadalafil daily for 1 week, then 20 mg daily for 1 week, and finally 40 mg daily for 50 weeks for a total therapy time of 52 weeks. Tadalafil will be taken orally in capsule form once daily.

Drug: Tadalafil

10 mg once daily orally week 1, 20 mg once daily orally during week 2, and 40 mg once daily orally during weeks 3 through 52

Placebo Comparator: Placebo Group

Study participants will receive a placebo capsule that looks identical to the Tadalafil capsule. The placebo will be taken orally once daily for 52 weeks.

Drug: Placebo

Looks exactly like the study drug, but it contains no active ingredient

Outcome Measures

Primary Outcome Measures

Microvascular endothelial function [52 weeks]
Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)
Pulmonary vascular reserve [52 weeks]
The slope of mean pulmonary artery pressure / cardiac output (mPAP/CO)

Secondary Outcome Measures

Liver stiffness [52 weeks]
Liver magnetic resonance elastography (MRE) will be used to assess liver stiffness expressed in Pascals (Pa)
Renal function [52 weeks]
Measured by the glomerular filtration rate
Exercise capacity [52 weeks]
Assessed using peak VO2 (oxygen consumption) obtained from an upright treadmill or supine bike cardiopulmonary exercise test with echocardiogram
Patient reported quality of life [52 weeks]
Measured by the Minnesota Living with Heart Failure Questionnaire that asks subjects to rate how much their heart failure (heart condition) has affected their life during the past month (4 weeks) on a scale of 0=no and 5=very much.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients ≥ 18 years old.
Have previously undergone a Fontan Palliation.
Able to exercise using a supine bike.
Able to undergo an MRI.
Ability and willingness to provide written consent.
Undergoing a clinically indicated Cardiac Catheterization

Exclusion Criteria:

Patients < 18 years old.
Current intravenous inotropic drugs.
Current use of alpha-blockers, pulmonary vasodilators, or nitrates.
Unable to exercise.
Pregnancy or lactating.
Unable or unwilling to consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Halley Davison	Rochester	Minnesota	United States	55902

Sponsors and Collaborators

Mayo Clinic
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator: Alexander C Egbe, MBBS, MPH, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Alexander C. Egbe, Principal Investigator, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT05206955

Other Study ID Numbers:

21-009890
R01HL160761-01

First Posted:

Jan 25, 2022

Last Update Posted:

Mar 18, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tadalafil

Study Results

No Results Posted as of Mar 18, 2022