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Ketone Ester for Heart Failure (HFrEF Trial)

Phase 2
Waitlist Available
Led By Senthil Selvaraj, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed 20 minutes after the intervention

Summary

This trial is looking at how a ketone drink can impact exercise capacity and other heart-related factors in patients with heart failure. Patients with heart failure often struggle with fatigue and shortness of breath, limiting

Who is the study for?
This trial is for people with heart failure who have a reduced ability of the heart to pump blood (ejection fraction of 45% or less) and experience moderate symptoms like getting tired or short of breath easily. They should be on stable heart medication for at least two weeks.
What is being tested?
The study is testing if a ketone drink, considered safe by the FDA but not yet approved for this use, can help improve exercise capacity and other heart-related functions in patients with heart failure.
What are the potential side effects?
Since the ketone ester drink has 'generally regarded as safe' status, significant side effects are not expected. However, potential risks may include gastrointestinal discomfort or allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 20 minutes after the intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 20 minutes after the intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximal exercise capacity
Submaximal exercise capacity
Secondary study objectives
Anaerobic threshold
Arterial stiffness
Left ventricular systolic function
+1 more
Other study objectives
Cardiac output
Heart rate variability
Left ventricular filling pressures
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ketone esterExperimental Treatment1 Intervention
(R)-3-hydroxybutyl (R)-3-hydroxybutyrate, a ketone ester
Group II: placeboPlacebo Group1 Intervention
KE-free solution

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,826 Previous Clinical Trials
8,166,489 Total Patients Enrolled
35 Trials studying Heart Failure
7,841 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,938 Previous Clinical Trials
47,792,273 Total Patients Enrolled
209 Trials studying Heart Failure
677,700 Patients Enrolled for Heart Failure
Duke UniversityLead Sponsor
2,458 Previous Clinical Trials
2,969,424 Total Patients Enrolled
64 Trials studying Heart Failure
46,672 Patients Enrolled for Heart Failure
American Heart AssociationOTHER
346 Previous Clinical Trials
4,971,152 Total Patients Enrolled
33 Trials studying Heart Failure
137,978 Patients Enrolled for Heart Failure
Senthil Selvaraj, MDPrincipal InvestigatorDuke University
~17 spots leftby Feb 2027
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