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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

Awards & highlights

HFrEF Trial 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.Check my eligibility

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.See study design

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.

HFrEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed 20 minutes after the intervention

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximal exercise capacity

Submaximal exercise capacity

Secondary outcome measures

Anaerobic threshold

Arterial stiffness

Left ventricular systolic function

+1 more

Other outcome measures

Cardiac output

Heart rate variability

Left ventricular filling pressures

+4 more

HFrEF 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH

2,698 Previous Clinical Trials

7,492,474 Total Patients Enrolled

35 Trials studying Heart Failure

7,861 Patients Enrolled for Heart Failure

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,832 Total Patients Enrolled

206 Trials studying Heart Failure

677,423 Patients Enrolled for Heart Failure

Duke UniversityLead Sponsor

2,363 Previous Clinical Trials

3,420,481 Total Patients Enrolled

63 Trials studying Heart Failure

46,492 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary goal of conducting this clinical trial?

"The primary aim of this investigation is to evaluate submaximal exercise capacity, assessed around 60 minutes post-intervention. Secondary goals encompass ventilatory efficiency, indicated by VE/VCO2 during cardiopulmonary exercise testing; anaerobic threshold, gauged through the same test; and left ventricular systolic function, determined by resting echocardiography measuring left ventricular ejection fraction."

Answered by AI

Has the ketone ester been granted approval by the FDA?

"In this Phase 2 trial, ketone ester is evaluated with a safety rating of 2 from Power's team due to available safety data without corresponding efficacy evidence."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ketones in Heart Failure With Reduced Ejection Fraction

2024. "Ketones in Heart Failure With Reduced Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06195982.

All > Heart Failure With Preserved Ejection Fraction