Testing a ketone supplement to help hospitalized heart failure patients recover

Plain-English translation of NCT06653725 on ClinicalTrials.gov ↗ · Source last updated June 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This study is testing a dietary supplement called 1,3-butanediol (brand name Ketone-IQ®) to see if it can help people hospitalized with acute heart failure feel better and recover faster. The medication provides ketone bodies—a special fuel source that your heart and brain use efficiently during stress. Researchers want to know if taking this supplement for 30 days improves how well the heart works, reduces symptoms, and helps patients walk farther than a placebo.

Acute heart failure is a serious, life-threatening condition, and current treatments don't always improve survival rates. Early research suggests that ketone-based supplements may help the heart pump more effectively and reduce the stress on the body during a heart failure crisis, but doctors need to test this in a larger group of patients to be sure.

Do you qualify?

You likely qualify if…

you are 18 years or older and have been hospitalized with acute heart failure as your main diagnosis
you have symptoms such as shortness of breath at rest, shortness of breath with minimal activity, or unusual fatigue
you have physical signs of worsening heart failure, such as swelling in your legs, belly fluid buildup, crackling sounds in your lungs, or rapid weight gain from fluid retention
you have a weakened heart pumping function (ejection fraction of 35% or lower) confirmed by an ultrasound of your heart during this hospitalization
you have received or are receiving intravenous diuretics, blood pressure medications, or heart-strengthening medications since admission

You likely don't qualify if…

your heart failure was triggered by a serious abnormal heart rhythm that is not yet controlled
you are in severe cardiogenic shock (very low blood pressure despite medications) that is not responding to treatment
you may need a mechanical heart pump or artificial heart device
you had heart surgery within the past 3 days
you have a severe active infection, sepsis, severe anemia, or a severe flare-up of lung disease

What participation looks like

If you enroll, you would be randomly assigned to either receive the ketone supplement or a taste-matched placebo drink. You would take your assigned drink three times daily while you are in the hospital and for up to 30 days after discharge. You will have blood tests, heart ultrasounds, and a walking test to measure how well the treatment is working, and doctors will track your symptoms and any heart-related events over the month.

AI-generated summary from trial data · Jun 28, 2026 · Not medical advice

Trial locations(8 sites)

Denmark

Department of Cardiology, Aalborg University Hospital, Aalborg

Department of Cardiology, Aarhus University Hospital, Aarhus N

Department of Cardiology, Herlev-Gentofte Hospital, Copenhagen

Department of Cardiology, Rigshospitalet, Copenhagen

Department of Cardiology, Gødstrup Hospital, Herning, Denmark, Herning