NCT04442555 (KETO-AHF1) is a Phase 1 clinical trial of HVMN Ketone Ester in Acute Heart Failure, sponsored by University of Aarhus.

Who is sponsoring NCT04442555?

NCT04442555 is sponsored by University of Aarhus.

What drugs are being tested in NCT04442555?

Interventions in NCT04442555: HVMN Ketone Ester, Maltodextrin.

What condition does NCT04442555 study?

NCT04442555 studies Acute Heart Failure.

Is NCT04442555 still recruiting?

NCT04442555 is currently status unknown. Last updated 18 July 2022.

Last reviewed 2022-07-18 · How we verify

NCT04442555: KETO-AHF1

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Treatment With the Ketone Body 3-hydroxybutyrate in Patients With Acute Heart Failure

Status unknown Phase 1 Last updated 18 July 2022

What this trial tests

Phase 1 trial testing HVMN Ketone Ester in Acute Heart Failure in 12 participants. Status unknown.

Timeline

1 February 2020

Primary endpoint
30 March 2023

30 March 2023

Quick facts

Lead sponsor	University of Aarhus
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	12
Start date	1 February 2020
Primary completion	30 March 2023
Estimated completion	30 March 2023
Sites	1 location across Denmark

Drugs / interventions tested

HVMN Ketone Ester
Maltodextrin (MALTODEXTRIN) — full drug profile →

Conditions studied

Acute Heart Failure — all drugs for Acute Heart Failure →

Sponsor

University of Aarhus

Who can join

18 and older, male only, with Acute Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Acute heart failure is a potentially life-threatening condition, reaching mortality rates of up to 50% in advanced cases. The investigators have shown that infusion of ketone bodies increase cardiac output by 40% in stabile patients with chronic heart failure. However, there are no data showing the effects of ketone on patients with acute heart failure Objectives: To investigate the effect of ketone supplementation in patients with acute heart failure and cardiogenic shock, using two different types of oral ketone supplements. Methods: The investigators will conduct four randomized placebo-controlled studies, to investigate the hemodynamic effect of exogenous ketones in acute heart failure and cardiogenic shock. Perspectives: The present study will determine the potential beneficial effects of ketone supplements in patients with acute heart failure.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Ketones and the Heart: Metabolic Principles and Therapeutic Implications.
Matsuura TR, Puchalska P, Crawford PA, Kelly DP. · · 2023 · cited 123× · PMID 36996176 · DOI 10.1161/circresaha.123.321872
Advances in myocardial energy metabolism: metabolic remodelling in heart failure and beyond.
Sun Q, Karwi QG, Wong N, Lopaschuk GD. · · 2024 · cited 55× · PMID 39453987 · DOI 10.1093/cvr/cvae231
The therapeutic potential of ketones in cardiometabolic disease: impact on heart and skeletal muscle.
Soni S, Tabatabaei Dakhili SA, Ussher JR, Dyck JRB. · · 2024 · cited 18× · PMID 38193855 · DOI 10.1152/ajpcell.00501.2023
Enhancing of cerebral Abeta clearance by modulation of ABC transporter expression: a review of experimental approaches.
Loeffler DA. · · 2024 · cited 2× · PMID 38872626 · DOI 10.3389/fnagi.2024.1368200

Verify or expand the search:

Other recruiting trials for Acute Heart Failure

Currently open trials in the same condition.

NCT06587854 — a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure · recruiting
NCT07008365 — The Role of intraABDOminal Pressure and Point Of Care UltraSound to Guide Decongestive Therapy in Heart Failure · Phase 3 · recruiting
NCT06465498 — Investigating aCute heArt failuRe Decongestion Guided by Lung UltraSonography · NA · recruiting
NCT06597331 — Cardiac Assessment and Takotsubo-stunning Among COPD-exacerbations In-Hospital · recruiting
NCT06166654 — Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload · Phase 4 · recruiting

Other University of Aarhus trials

Trials by the same sponsor.

NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
NCT07317401 — Investigating the Effects of Intermittent Hypoxia-Hyperoxia Treatment (IHHT) in People With Post-Viral Myalgic Encephalo · NA · not yet recruiting
NCT07531966 — Vascular Complications After Kidney Transplantation · recruiting
NCT07528339 — Prospective RegIstry for Oncologic Reirradiation (PRIOR-DK) · not yet recruiting
NCT07451028 — Effect of an Oral Neuromuscular Training Device on Dysphagia · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04442555 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Aarhus
Last refreshed: 18 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04442555.

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