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Ketone Ester Drink
DeltaG Drink for Heart Failure
Phase 1
Waitlist Available
Led By Senthil Selvaraj, MD, MSTR, MA
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 1 hour
Awards & highlights
Study Summary
This trial tests whether an over-the-counter drink is safe for people with heart failure, on and off certain medications. A physical exam and blood draws are part of the half-day visit.
Who is the study for?
This trial is for adults with heart failure (HFrEF) who have an ejection fraction of 45% or less and a systolic blood pressure of at least 90 mmHg. It's not for those with unique heart conditions, Type 1 diabetes, pregnant women, people on ketogenic diets, severe kidney issues, those using certain heart devices or drugs, or individuals with significant liver disease.Check my eligibility
What is being tested?
The study is testing the tolerability and safest dose of DeltaG, a ketone ester drink. Participants will consume this drink during a single visit where they'll receive a light breakfast and undergo physical exams and multiple blood draws to assess the effects.See study design
What are the potential side effects?
While specific side effects are not listed here, participants may experience reactions related to the consumption of DeltaG which could include gastrointestinal discomfort or changes in blood sugar levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 hour
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 hour
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Beta-hydroxybutyrate level
Glucose
Systolic blood pressure
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: 500 mg/kg ketone esterExperimental Treatment1 Intervention
The second 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 500 mg/kg.
Group II: 250 mg/kg ketone esterExperimental Treatment1 Intervention
The first 5 patients within each SGLT2i stratum will receive ketone ester as (R)-3-hydroxybutyl (R)-3-hydroxybutyrate at 250 mg/kg.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DeltaG (500 mg/kg)
2023
Completed Phase 1
~20
DeltaG (250 mg/kg)
2023
Completed Phase 1
~20
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,374 Previous Clinical Trials
3,426,853 Total Patients Enrolled
63 Trials studying Heart Failure
46,497 Patients Enrolled for Heart Failure
American Heart AssociationOTHER
328 Previous Clinical Trials
4,934,000 Total Patients Enrolled
31 Trials studying Heart Failure
137,759 Patients Enrolled for Heart Failure
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,506 Total Patients Enrolled
206 Trials studying Heart Failure
677,458 Patients Enrolled for Heart Failure
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have certain heart conditions that the doctor believes are better treated with other options than the study's ketone therapy.You have type 1 diabetes.You have serious liver disease or drink a lot of alcohol regularly.You have been following a diet high in fat and low in carbohydrates on purpose. You need to stop this diet for more than 7 days before participating in the study.Your kidney function is very low, with an estimated glomerular filtration rate of less than 25 mL/min/1.73 m2 in the past year.You have a history of using a ventricular assist device, had a heart transplant, or used continuous inotropes.You have been diagnosed with heart failure with reduced ejection fraction (ejection fraction of 45% or less).Your systolic blood pressure is 90 mmHg or higher.
Research Study Groups:
This trial has the following groups:- Group 1: 500 mg/kg ketone ester
- Group 2: 250 mg/kg ketone ester
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
To what degree is Ketone ester a secure treatment option for sufferers?
"Our Power team appraised the safety of ketone ester to be a 1 due to limited clinical data for efficacy and safety in Phase 1 trials."
Answered by AI
Are there still opportunities to volunteer for this experiment?
"Per clinicaltrials.gov, this investigation is not currently recruiting participants; it was posted on March 1st of 2023 and last updated February 24th of the same year. Although this trial does not require volunteers at present, there are 710 other trials actively looking to find people who can help with their research efforts."
Answered by AI
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