Ketone Ester for Heart Failure

(KETO-AHF Trial)

FG
JE
Overseen ByJustin Ezekowitz, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alberta

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether ketone esters, a type of supplement, can aid individuals with acute heart failure (AHF). The treatment may supply energy to the heart and protect other organs. Participants will receive either ketone esters or a placebo for five days during their hospital stay. Ideal candidates for this trial include those admitted for AHF with breathing difficulties and signs of fluid buildup, such as swelling or lung congestion. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new heart failure treatments.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ketone ester treatment is likely to be safe for humans?

Research has shown that ketone esters, such as KetoneAid MonoEster, are generally safe and well-tolerated. In previous studies, individuals with stable heart failure who took ketone esters for 14 days experienced positive effects on their hearts without major side effects. Another study found that taking up to 25 grams of a different ketone ester daily for 12 weeks was safe and tolerable.

Additionally, ketone esters have improved important heart functions, such as enhancing the heart's ability to pump blood effectively. This improvement occurred both at rest and during exercise. These findings suggest that ketone esters could benefit heart failure patients without causing significant harm.12345

Why are researchers excited about this trial?

Most treatments for heart failure focus on improving heart function or managing symptoms with medications like beta-blockers, ACE inhibitors, or diuretics. But KetoneAid MonoEster works differently, targeting the body's metabolism by introducing ketone esters. Researchers are excited about this treatment because ketone esters can provide an alternative energy source for heart cells, potentially improving energy efficiency and function. Unlike traditional heart failure drugs that take weeks to show effects, KetoneAid MonoEster could offer benefits in just a few days.

What evidence suggests that ketone ester might be an effective treatment for heart failure?

Research has shown that ketone esters benefit heart health. Studies have found that ketone esters help the heart pump blood more effectively. In people with heart failure, ketone esters improved heart function and reduced blood pressure. Some research also suggests they enhance the oxygen supply to the body's tissues. Additionally, ketone esters may help manage blood sugar levels, which benefits heart health. Overall, these findings suggest that ketone esters could be a promising treatment for heart failure symptoms. Participants in this trial will receive either the KetoneAid MonoEster or a matching placebo to evaluate its effectiveness in treating heart failure symptoms.12356

Who Is on the Research Team?

FG

Fernando G Zampieri, MD, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for adults recently hospitalized (within 48 hours) with acute heart failure, who have high NT-proBNP levels and symptoms like shortness of breath plus signs of fluid buildup. Participants must have some kidney function left.

Inclusion Criteria

4. NT-proBNP ≥ 1000 pg/ml
I have acute heart failure with shortness of breath and at least two signs of fluid buildup.
I have been in the hospital for less than 48 hours.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 days
1 visit (in-person)

Treatment

Participants receive ketone ester therapy or placebo for up to 5 days

5 days
Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
Regular follow-up (in-person or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Ketone Ester (KetoneAid MonoEster)

Trial Overview

The study randomly assigns patients to receive either a ketone ester drink or a placebo three times daily for up to five days while in the hospital. The goal is to see if ketone esters help improve heart failure symptoms and related health markers.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: KetoneAid MonoEsterExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials
957
Recruited
437,000+

University Hospital Foundation

Collaborator

Trials
8
Recruited
1,800+

Canadian VIGOUR Centre

Collaborator

Trials
9
Recruited
11,000+

Citations

Cardiovascular Effects of Oral Ketone Ester Treatment in ...

The results of this study demonstrate favorable cardiovascular effects of 14-day ketone ester treatment in patients with stable heart failure ...

Ketone Ester for Treatment Of Acute Heart Failure

Ketones have been suggested to have significant physiological effects in patients with heart failure. Potential mechanisms for these effects include energy ...

Ketone Ester Treatment Improves Cardiac Function and ... - PMC

Conclusions: Chronic oral supplementation with KE was effective in both prevention and treatment of heart failure in 2 preclinical animal models. In addition, ...

Beneficial Effects of Ketone Ester in Patients With ...

Treatment with KE improved cardiac output, biventricular function, tissue oxygenation, and glycemic control in patients with CS.

Ketone Ester for Heart Failure (KETO-AHF Trial)

Ketones have been suggested to have significant physiological effects in patients with heart failure. Potential mechanisms for these effects ...

Daily consumption of ketone ester, bis-octanoyl (R)

In conclusion this pilot study demonstrated the safety and tolerability of 12-weeks of consumption of up to 25 g per day of the ketone di-ester, bis-octanoyl (R)- ...