Acute Effects of Exogenous Ketone Ester Administration in Heart Failure
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Maximal Exercise Capacity (Peak VO2) Assessed by Cardiopulmonary Exercise Testing
Study Overview
Brief 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.
Detailed Description
This is a randomized, crossover trial of ketone ester versus placebo in 20 patients with heart failure with preserved ejection fraction. Participants come for a baseline assessment. If they meet eligibility criteria, they are randomized to receive ketone ester first or placebo first. After approximately a week washout period, participants return for the last visit to receive the product they did not receive at the previous visit.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Maximal Exercise Capacity (Peak VO2) Assessed by Cardiopulmonary Exercise Testing
Time Frame: Assessed 60 minutes after the intervention.
Peak VO2
Submaximal Exercise Capacity (Exercise Time at 75% of Peak Workload) Assessed by Cardiopulmonary Exercise Testing.
Time Frame: Assessed 30 minutes after the intervention.
Exercise time at 75% of peak workload
Secondary Outcomes
- Percent Change in Systemic Vascular Resistance With Exercise(Assessed 60 minutes after the intervention.)
- Substrate Utilization (Reflected by the Respiratory Exchange Ratio) Assessed by Cardiopulmonary Exercise Testing.(Assessed 60 minutes after the intervention.)
- VO2 Efficiency (Total Work Performed Over Oxygen Consumed) During Submaximal Cardiopulmonary Exercise Testing.(Assessed 60 minutes after the intervention.)
- Presence of Exercise-induced Arrhythmias (Significant Atrial or Ventricular Arrhythmias)(Assessed throughout the study visit date after the intervention is given (until leaving the research study center that day).)
Investigators
Kenneth B Margulies
Professor of Medicine
University of Pennsylvania