NCT05206955View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 16, 2022

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Fontan Palliation
Interventions
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

DRUG

Placebo

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

Trial Locations (1)

55905

RECRUITING

Mayo Clinic, Rochester

Sponsors

Lead Sponsor

Mayo Clinic
All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Mayo Clinic

OTHER

NCT05206955 - Study of Tadalafil Vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology | Biotech Hunter | Biotech Hunter