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NCT04195451 · ClinicalTrials.gov registry record · NA
Re-Energize Fontan
A NA study of Single-ventricle, sponsored by Stanford University.
- Recruiting
- Registry status
- NA
- Development phase
- 150
- Enrollment target
- 1
- Study location
NCT04195451 is a NA study of Single-ventricle that is actively recruiting participants, run by Stanford University. The registered enrollment target is 150 participants, above the 78-participant average among 17 other Single-ventricle trials with a reported enrollment target (92% higher). The trial reports 1 study location across 1 state.
The verdict
NCT04195451, a NA study of Single-ventricle, is actively recruiting participants, sponsored by Stanford University.
- RECRUITING
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
- 1
- Study location
Study Summary
Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With \>1,000 Fontan palliations performed in the US annually, there is a burgeoning population of Fontan patients at risk for progressive heart failure and death. Factors that contribute to onset and progression of heart failure in Fontan patients remain incompletely understood. However, it is established that Fontan patients have poor exercise capacity, associated with a greater risk of morbidity and mortality, in addition to decreased muscle mass, abnormal muscle function, and endothelial dysfunction contributing to disease progression. In adult patients with two ventricles and heart failure, reduced exercise capacity, muscle mass, and muscle strength are powerful predictors of poor outcomes, and exercise interventions can not only improve exercise capacity and muscle mass, but also reverse endothelial dysfunction. Limited exercise interventions in children with congenital heart disease have demonstrated that exercise is safe and effective; however, these studies have been conducted in small, heterogeneous groups, and most had few Fontan patients. Furthermore, none of these interventions have studied the impact of exercise on muscle mass or mitochondrial function, or endothelial function. The investigators propose a milestone-driven, randomized controlled trial in pediatric Fontan patients to test the hypothesis that a live-video-supervised exercise (aerobic + resistance) intervention will improve cardiac and physical capacity; muscle mass, strength and function; and endothelial function. The investigators' ultimate goal is the translation of this model to clinical application as an "exercise prescription" to intervene early in pediatric Fontan patients and decrease long-term morbidity an
Conditions Studied
Interventions
- OTHER Live-Video-Supervised Exercise Intervention
- OTHER Usual Care then Live-Video Supervised Exercise Intervention
Study Locations (1)
California
- Stanford University, Lucile Packard Children Hospital - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2020-08-06 |
| Est. Completion | 2026-03-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04195451
The ClinicalTrials.gov registry entry for NCT04195451 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 78-participant average among 17 other Single-ventricle trials with a reported enrollment target (92% higher). The listed sponsor is Stanford University, which has 1,744 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Single-ventricle appearing as the primary indexed condition, and to 2 interventions - of which Live-Video-Supervised Exercise Intervention is the first listed.
NCT04195451 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04195451 about?
NCT04195451 is a clinical study titled "Re-Energize Fontan". Survival of children with single ventricles ("half a heart") beyond the neonatal period has increased dramatically with the staged Fontan palliation. Yet, long-term morbidity remains high. By the age of 40, 50% of Fontan patients will have died or undergone heart transplantation. With \>1,000 Fontan...
What is the current status of trial NCT04195451?
This trial is currently recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2020-08-06. Estimated completion is 2026-03-01.
What conditions does trial NCT04195451 study?
This clinical trial studies the following conditions: Single-ventricle.
What interventions are being tested in trial NCT04195451?
The interventions under investigation include: Live-Video-Supervised Exercise Intervention (OTHER), Usual Care then Live-Video Supervised Exercise Intervention (OTHER).
Who is sponsoring clinical trial NCT04195451?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04195451 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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