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NCT05206955 · ClinicalTrials.gov registry record · Phase 3
Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology
A Phase 3 study of Fontan Palliation, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT05206955: Recruiting Phase 3 study of Fontan Palliation, sponsored by Mayo Clinic.
NCT05206955 is a Phase 3 study of Fontan Palliation that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 80 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05206955, a Phase 3 study of Fontan Palliation, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Measured by the reactive hyperemic index using peripheral artery tonometry (EndoPAT)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Tadalafil
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-09-16 |
| Est. Completion | 2026-11 |
| Phase | Phase 3 |
What NCT05206955 shows while recruiting
NCT05206955 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Fontan Palliation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05206955 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05206955 about?
NCT05206955 is a clinical study titled "Study of Tadalafil vs. Placebo for Improving Hemodynamics and End-Organ Dysfunction in Fontan Physiology". 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.
What is the current status of trial NCT05206955?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2022-09-16. Estimated completion is 2026-11.
What conditions does trial NCT05206955 study?
This clinical trial studies the following conditions: Fontan Palliation.
What interventions are being tested in trial NCT05206955?
The interventions under investigation include: Placebo (DRUG), Tadalafil (DRUG).
Who is sponsoring clinical trial NCT05206955?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05206955 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Fontan Palliation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05206955's enrollment target sits among peer trials
80 1756th of 2000 higher than 233 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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