NCT04443426 (KETO-KINETICS1) is a Phase 2 clinical trial of Oral 3-hydroxybutyrate salts in Heart Failure, sponsored by University of Aarhus.

Who is sponsoring NCT04443426?

NCT04443426 is sponsored by University of Aarhus.

What drugs are being tested in NCT04443426?

Interventions in NCT04443426: Oral 3-hydroxybutyrate salts, Carbohydrate Placebo, Ketone Monoester.

What condition does NCT04443426 study?

NCT04443426 studies Heart Failure, Ketosis, Ketonemia.

Is NCT04443426 still recruiting?

NCT04443426 is currently status unknown. Last updated 18 August 2022.

Last reviewed 2022-08-18 · How we verify

NCT04443426: KETO-KINETICS1

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

Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects

Status unknown Phase 2 Last updated 18 August 2022

What this trial tests

Phase 2 trial testing Oral 3-hydroxybutyrate salts in Heart Failure in 8 participants. Status unknown.

Timeline

25 April 2019

Primary endpoint
1 November 2022

1 November 2022

Quick facts

Lead sponsor	University of Aarhus
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	8
Start date	25 April 2019
Primary completion	1 November 2022
Estimated completion	1 November 2022
Sites	1 location across Denmark

Drugs / interventions tested

Oral 3-hydroxybutyrate salts
Carbohydrate Placebo
Ketone Monoester

Conditions studied

Heart Failure — all drugs for Heart Failure →
Ketosis — all drugs for Ketosis →
Ketonemia — all drugs for Ketonemia →

Sponsor

University of Aarhus

Who can join

18 and older, any sex, with Heart Failure or Ketosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The ketone body 3-hydroxybutyrate (3-OHB) is a naturally occurring energy substrate, and is associated with increased life span and improved health. We have previously shown that intravenous 3-OHB treatment increases myocardial blood flow \> 70% in healthy humans and data from our group show that 3-OHB increases cardiac output by 40 % in patients with heart failure. In this study the investigators aim to investigate: 1. If this effect is reproducible with a commercially available oral ketone supplements 2. The safety of commercially available ketone supplements in heart failure patients

Publications & conference data

2 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
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

Verify or expand the search:

Other recruiting trials for Heart Failure

Currently open trials in the same condition.

NCT06118983 — Improving TRansitions ANd OutcomeS for Heart FailurE Patients in Home Health CaRe (I-TRANSFER-HF) · NA · recruiting
NCT07496372 — Efficacy and Safety of Human Induced Pluripotent Stem Cell-Derived Cardiomyocyte Injection (HiCM-188) in Advanced Heart · Phase 3 · recruiting
NCT07527156 — Prolonged Nasogastric Administration of Ketones in Decompensated Heart Failure · Phase 4 · recruiting
NCT07263035 — Urine Sodium-Driven Diuretic Adjustment Strategy in Acute Decompensated Heart Failure · Phase 4 · recruiting
NCT07531966 — Vascular Complications After Kidney Transplantation · 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 NCT04443426 (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 August 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/NCT04443426.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing