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NCT04908397 · ClinicalTrials.gov registry record · Phase 1
Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension
A Phase 1 study, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04908397: Completed Phase 1 study, sponsored by Vanderbilt University Medical Center.
NCT04908397 is a Phase 1 study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04908397, a Phase 1 study, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
In preparation for a future mechanistic study, investigators now propose to test the specific hypothesis that carnitine consumption is not reduced in PAH, that plasma carnitine levels are stable over time in PAH and that carnitine supplementation in PAH can increase plasma carnitine and thereby delivery of carnitine to the RV and possibly improve RV function. Investigators propose three aims in humans to test this mechanistic hypothesis, 1) Measure the oral consumption of carnitine in human PAH. This aim will use food diaries and carnitine supplement use questionnaires in PAH patients to test the hypothesis that carnitine supplementation is uncommon in PAH and food consumption is adequate. Aim 2) Measure the stability over time in plasma carnitine levels in PAH patients. This aim will test the hypothesis that plasma carnitine is not affected by disease severity and is stable over time in PAH patients. Investigators will measure plasma carnitine concentration and markers of fatty acid oxidation at Visit 1 and Visit 2. 3) Perform a mechanistic pilot study using carnitine supplementation to enhance circulating carnitine in PAH. This small pilot study will test the hypothesis that carnitine supplementation increases plasma carnitine (primary endpoint) and will test for physiologic effects using six minute walk testing, echocardiography and plasma markers of lipid metabolism.
Primary Outcome
Change in plasma Carnitine concentration from Visit 2 (Week 12) to Visit 4 (Week 14).
Interventions
- DIETARY_SUPPLEMENT L-carnitine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2021-09-29 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 1 |
What the finished NCT04908397 record still lists
NCT04908397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which L-carnitine is the first listed.
NCT04908397 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04908397 about?
NCT04908397 is a clinical study titled "Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension". In preparation for a future mechanistic study, investigators now propose to test the specific hypothesis that carnitine consumption is not reduced in PAH, that plasma carnitine levels are stable over time in PAH and that carnitine supplementation in PAH can increase plasma carnitine and thereby deli...
What is the current status of trial NCT04908397?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2021-09-29. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT04908397?
The interventions under investigation include: L-carnitine (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04908397?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04908397's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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