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NCT04633460 · ClinicalTrials.gov registry record · Phase 2
Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT04633460: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT04633460 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 26 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04633460, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to test whether a ketone ester drink will improve exercise in people with heart failure (HF) compared to a placebo. In HF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short of breath early. There may be several reasons why these symptoms occur. There is some evidence that in addition to problems with the heart, patients with HF also have problems with their arteries and muscles that affect their ability to exercise. Ketones have been shown to improve exercise capacity in healthy volunteers, which may be related to effects on the heart function or on muscles. An infusion of ketones through an intravenous (IV) line has also been shown to significantly improve heart function, but whether a drink can produce similar improvements in HF patients is not known. This drink has been given status by Food and Drug Administration as "generally regarded as safe". The use of DeltaG in this study is experimental. DeltaG has not been approved by the Food and Drug Administration (FDA) for the use being evaluated in this study.
Interventions
- DIETARY_SUPPLEMENT Ketone ester
- DIETARY_SUPPLEMENT placebo drink
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-10-06 |
| Est. Completion | 2023-10-16 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04633460
The ClinicalTrials.gov registry entry for NCT04633460 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ketone ester is the first listed.
NCT04633460 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04633460 about?
NCT04633460 is a clinical study titled "Acute Effects of Exogenous Ketone Ester Administration in Heart Failure". The purpose of this study is to test whether a ketone ester drink will improve exercise in people with heart failure (HF) compared to a placebo. In HF, patients are limited in their ability to do all the things they want to do, and exercise as much as they would like, due to becoming tired and short...
What is the current status of trial NCT04633460?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2020-10-06. Estimated completion is 2023-10-16.
What interventions are being tested in trial NCT04633460?
The interventions under investigation include: Ketone ester (DIETARY_SUPPLEMENT), placebo drink (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT04633460?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
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