Exogenous KETOne Supplements in Patients Hospitalized for Acute Heart Failure. A Randomized Clinical Trial (KETO-AHF)

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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 laboratory criterion:

• a) Physical examination findings considered to be due to heart failure, including new or worsened: i. Peripheral edema ii. Increasing abdominal distention or ascites (in the absence of primary hepatic disease) iii. Pulmonary rales/crackles/crepitations iv. Increased jugular venous pressure and/or hepatojugular reflux v. S3 gallop vi. Clinically significant or rapid weight gain thought to be related to fluid retention b) Laboratory evidence of worsening HF, if obtained within 24 hours of presentation, including: i. Increased B-type natriuretic peptide (BNP) / N-terminal pro-BNP (NT-proBNP) concentrations consistent with decompensation of heart failure. In patients with chronically elevated natriuretic peptides, an increase of \>30% above baseline should be noted.

• ii. Radiological evidence of pulmonary congestion iii. Echocardiographic criteria include: Dilated inferior vena cava with minimal collapse on inspiration; decreased left ventricular outflow tract (LVOT) minute stroke distance (velocity time integral \[VTI\]); septal or lateral E/e' \>15 or \>12, respectively; D-dominant pulmonary venous inflow pattern.

• iv. Invasive diagnostic evidence with right heart catheterization showing a pulmonary capillary wedge pressure ≥18 mmHg, central venous pressure ≥12 mmHg, or a cardiac index \<2.2 L/min/m2

• 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 or BNP ≥225 pg/mL.

⁃ The enrollment window extends to the first five days of the hospital stay.

Locations
Other Locations
Denmark
Department of Cardiology, Aalborg University Hospital
NOT_YET_RECRUITING
Aalborg
Department of Cardiology, Aarhus University Hospital
RECRUITING
Aarhus N
Department of Cardiology, Herlev-Gentofte Hospital
RECRUITING
Copenhagen
Department of Cardiology, Rigshospitalet
NOT_YET_RECRUITING
Copenhagen
Department of Cardiology, Gødstrup Hospital, Herning, Denmark
RECRUITING
Herning
Department of Cardiology, Copenhagen University Hospital - Amager and Hvidovre Hospital
RECRUITING
Hvidovre
Department of Cardiology, Odense University Hospital
NOT_YET_RECRUITING
Odense
Department of Cardiology, Viborg Hospital
RECRUITING
Viborg
Contact Information
Primary
Kristoffer Berg-Hansen, MD, PhD
krisbe@rm.dk
+4560540700
Backup
Henrik Wiggers, MD, PHD, DMSc
henrikwiggers@dadlnet.dk
Time Frame
Start Date: 2025-03-20
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 250
Treatments
Experimental: 1,3-butanediol
1,3-butanediol (Ketone-IQ®) 118 mL (33 g) servings trice daily
Placebo_comparator: Placebo
Taste-matched placebo (isovolumic, isoviscous water with stevia) 118 mL servings trice daily
Related Therapeutic Areas
Sponsors
Collaborators: Hospitalsenhed Vest, Herning, Viborg Regional Hospital, Odense University Hospital, Copenhagen University Hospital, Amager-Hvidovre, Denmark, Copenhagen University Hospital at Herlev, Aalborg University Hospital, Rigshospitalet, Denmark
Leads: Aarhus University Hospital

This content was sourced from clinicaltrials.gov