Ketone Ester for Treatment Of Acute Heart Failure (NCT07434466) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Ketone Ester for Treatment Of Acute Heart Failure
Canada60 participantsStarted 2026-07
Plain-language summary
Ketones have been suggested to have significant physiological effects in patients with heart failure. Potential mechanisms for these effects include energy provision for the failing heart and direct protective effects on other organs. Despite the strong physiological rationale, the acute effects of ketone therapy in patients with acute heart failure (AHF) is unclear. AHF is a major healthcare issue, with in-hospital mortality exceeding 10%. Therefore, we propose a vanguard randomized controlled trial to assess the effects of ketone esters in patients with AHF. Sixty patients hospitalized with AHF will be randomized to receive either 25 grams of ketone esters three times per day or a matching placebo for five days, or until death or hospital discharge. We hypothesize that ketone therapy will improve markers of systemic congestion and heart failure symptoms. Primary endpoint will be changes in NT-proBNP levels during therapy. Secondary endpoints will be KCCQ scores, and hemodynamic profile as assessed by echocardiogram. Exploratory endpoints will clinical outcomes including mortality, need for intensive care unit admission, among others.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Primary diagnosis of AHF with dyspnea on exertion or at rest, and at least two of the following: congestion on chest radiograph, rales on chest auscultation, clinically relevant edema, or an elevated jugular venous pressure \[21\]
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a ketone ester drink — not a standard drug — for acute heart failure, and the phase is listed as 'NA,' which means it doesn't fit the usual Phase 1–3 framework; can you help me understand what that means for how much is already known about its safety and effectiveness?
2The trial is measuring change in NT-proBNP as its main outcome — that's a blood marker for heart stress — so can you explain whether a drop in that number would actually translate into me feeling better or leaving the hospital sooner, or is it just a lab signal at this stage?
3Since this trial isn't recruiting yet, how long do you think it might be before it opens, and in the meantime, what standard treatments are available for acute heart failure that I should be considering right now?
4Ketone esters are a type of nutritional supplement that changes how the heart gets its energy — do you know of any concerns about giving something like that during an acute heart failure episode, especially if I have other conditions or take certain medications?
5If this trial does open and I might be a candidate, what would participation actually look like in terms of how long I'd need to be in the hospital, how often I'd be monitored, and whether it could affect my access to other standard-of-care treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in NT-proBNP
Timeframe: Baseline to Day 5 (or hospital discharge if earlier)