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Ketone Ester

Ketone Ester for Heart Failure

Phase 2
Waitlist Available
Research Sponsored by University of Pennsylvania
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

Study Summary

This trial will test whether a ketone ester drink can help people with heart failure exercise more by improving heart function or muscles. The drink is "generally regarded as safe" by the FDA.

Eligible Conditions
  • Diastolic Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed 30 minutes after the intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed 30 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 (peak VO2) assessed by cardiopulmonary exercise testing
Submaximal exercise capacity (exercise time at 75% of peak workload) assessed by cardiopulmonary exercise testing.
Secondary outcome measures
Percent change in systemic vascular resistance with exercise
Presence of exercise-induced arrhythmias (significant atrial or ventricular arrhythmias)
Substrate utilization (reflected by the respiratory exchange ratio) assessed by cardiopulmonary exercise testing.
+1 more
Other outcome measures
E/e' ratio measured during stress echocardiography.
Exercise-induced extravascular lung water (B-lines) assessed during lung ultrasound with exercise.
Heart rate variability at rest
+3 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ketone ester
2023
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,000 Previous Clinical Trials
42,880,068 Total Patients Enrolled
42 Trials studying Heart Failure
7,494 Patients Enrolled for Heart Failure

Media Library

Ketone ester (Ketone Ester) Clinical Trial Eligibility Overview. Trial Name: NCT04633460 — Phase 2
Heart Failure Research Study Groups: Ketone ester, Placebo
Heart Failure Clinical Trial 2023: Ketone ester Highlights & Side Effects. Trial Name: NCT04633460 — Phase 2
Ketone ester (Ketone Ester) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04633460 — Phase 2

Frequently Asked Questions

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

What are the eligibility requirements for participating in this research study?

"Patients aged between 18 and 85, who have been diagnosed with heart failure with preserved ejection fraction (hfpef) are invited to take part in this medical trial. To be eligible they must also possess an enlarged left atrium, display New york Heart Association class II or III symptoms, and present a Mitral E/e' ratio exceeding 14."

Answered by AI

Has the FDA granted approval for Ketone ester?

"Ketone ester has undergone some safety testing, which justifies its score of 2 on the 1-3 scale. However, there is yet to be any efficacy data generated for this medication."

Answered by AI

Is this experiment open to participants above the age of twenty-five?

"The enrollment criteria for this clinical trial necessitates that participants are aged between 18 and 85."

Answered by AI

What is the cap for enrollment in this medical research study?

"Affirmative. The clinicaltrial.gov portal attests that this medical trial is currently enrolling participants, with the first posting on October 6th 2020 and a recent update on November 11th 2022. Specifically, 20 people are sought for research at 1 center of study."

Answered by AI

Is the recruitment process for this research endeavor still open?

"Affirmative. Clinicaltrials.gov confirms that this medical experiment, which was first unveiled on October 6th 2020, is currently recruiting participants. As many as 20 individuals need to be signed up from a single location."

Answered by AI
~4 spots leftby Apr 2025