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New treatment option for Acute Heart Failure (AHF)
Official title Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure
ClinicalTrials.gov ID: NCT06653725
What this study is testing
- What it's testing
- This is a multicenter, randomized, double-blind, placebo-controlled trial to investigate the clinical efficacy of treatment with exogenous dietary ketone supplement containing 1,3-butanediol in patients hospitalized with acute heart failure (AHF), potentially leading to better clinical outcomes.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The study will enroll adult patients (≥18 years) admitted with AHF as the primary diagnosis, meeting all the following criteria:
- Documented new or worsening symptoms due to heart failure with at least one of the following: persistent dyspnea at rest or with minimal exertion, or...
- Objective evidence of worsening heart failure, consisting of at least two physical examination findings consistent with fluid retention and/or...
- Treatment with at least 40 mg of intravenous furosemide or its equivalent and/or intravenous vasoactive drugs and/or inotropic drugs.
- An LVEF of ≤35% is required, measured during the present hospitalization.
You likely can't join if
- Current hospitalization for AHF triggered by significant arrhythmia (atrial fibrillation/flutter with sustained ventricular response \>110 beats per...
- Cardiogenic shock in INTERMACS level 1 or 2 (i.e. unstable hemodynamics despite inotropic/vasopressor therapy)
- Likelihood or current use of mechanical circulatory support
- Recent cardiac surgery within 3 days
- Ongoing severe infection or sepsis, severe anemia, acute exacerbation of chronic obstructive pulmonary disease, pulmonary embolism, or...
- Significant primary valvular disease (hemodynamically severe uncorrected primary cardiac valvular disease)
See the full eligibility criteria
- The study will enroll adult patients (≥18 years) admitted with AHF as the primary diagnosis, meeting all the following criteria:
- Documented new or worsening symptoms due to heart failure with at least one of the following: persistent dyspnea at rest or with minimal exertion, or fatigue.
- Objective evidence of worsening heart failure, consisting of at least two physical examination findings consistent with fluid retention and/or end-organ hypoperfusion or one physical examination finding and at least one...
- Treatment with at least 40 mg of intravenous furosemide or its equivalent and/or intravenous vasoactive drugs and/or inotropic drugs.
- An LVEF of ≤35% is required, measured during the present hospitalization.
- Participants must present with elevated levels of natriuretic peptides, specifically NT-proBNP ≥600 pg/mL or BNP ≥150 pg/mL. For those in atrial fibrillation at the time of inclusion, NT-proBNP levels must be ≥900 pg/mL...
- Current hospitalization for AHF triggered by significant arrhythmia (atrial fibrillation/flutter with sustained ventricular response \>110 beats per minute, clinically significant bradycardia, or sustained ventricular...
- Cardiogenic shock in INTERMACS level 1 or 2 (i.e. unstable hemodynamics despite inotropic/vasopressor therapy)
- Likelihood or current use of mechanical circulatory support
- Recent cardiac surgery within 3 days
- Ongoing severe infection or sepsis, severe anemia, acute exacerbation of chronic obstructive pulmonary disease, pulmonary embolism, or cerebrovascular accident
- Significant primary valvular disease (hemodynamically severe uncorrected primary cardiac valvular disease)
- Planned implantation of a cardiac resynchronization therapy device
- eGFR \<15 mL/min/1.73 m2 during current hospitalization (unless ongoing continuous renal replacement therapy) or recurring dialysis
- Known obstructive hypertrophic cardiomyopathy, congenital heart disease, acute mechanical cause of acute heart failure (e.g., papillary muscular rupture), acute myocarditis, or constrictive pericarditis according to the...
- Type 1 diabetes
- Advanced liver disease (Child-Pugh class C)
- Dementia or other cognitive disorder making the patient unable to give informed consent
- Pregnancy or breastfeeding
- Inability to intake oral substances or severe dysphagia
- Significant gastrointestinal disease (i.e. severe inflammatory bowel disease or gastric ulcer)
- Adherent to a ketogenic diet within 30 days of enrollment
- Awaiting cardiac transplantation
- Very severe lung disease and/or treatment with continuous home oxygen therapy
- Major comorbidity, medical condition, or health issue that, according to the investigator's judgment, would hinder the participant's capacity to engage in or successfully finish the study
The study team makes the final eligibility decision.
Where it's taking place
- Aalborg, Denmark
- Aarhus N, Denmark
- Copenhagen, Denmark
- Herning, Denmark
- Hvidovre, Denmark
- Odense, Denmark
- Viborg, Denmark
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalborg, Denmark; Aarhus N, Denmark; Copenhagen, Denmark; Herning, Denmark; Hvidovre, Denmark; Odense, Denmark and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.