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NCT05236335: KETO-HFpEF
Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction: Cardiovascular Effects.
NA trial testing Ketone ester in Heart Failure With Preserved Ejection Fraction in 24 participants. Completed in 15 June 2023.
15 June 2023
Quick facts
| Lead sponsor | University of Aarhus |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 24 |
| Start date | 1 February 2022 |
| Primary completion | 15 June 2023 |
| Estimated completion | 15 June 2023 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Ketone ester
- Placebo drink — full drug profile →
Conditions studied
- Heart Failure With Preserved Ejection Fraction — all drugs for Heart Failure With Preserved Ejection Fraction →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Ketonemia — all drugs for Ketonemia →
Sponsor
University of Aarhus
Who can join
18 and older, any sex, with Heart Failure With Preserved Ejection Fraction or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Heart failure (HF) is among the most common causes of death in patients with type 2 diabetes (T2D). Ketones, 3-hydroxybutyrate (3-OHB), have shown to have beneficial hemodynamics effect in patients with hearth failure with reduced ejection fraction. However, this have never been investigated in patients with heart failure with preserved ejection fraction (HFpEF). In this study we would like to investigate the effect of 14 days modulation of circulating ketone body levels on cardiac function and exercise capacity in patients with HFpEF and T2D.
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 -
Randomized Crossover Trial of 2-Week Ketone Ester Treatment in Patients With Type 2 Diabetes and Heart Failure With Preserved Ejection Fraction.
Gopalasingam N, Berg-Hansen K, Christensen KH, Ladefoged BT, et al · · 2024 · cited 43× · PMID 39162035 · DOI 10.1161/circulationaha.124.069732 -
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 -
Ketones in Cardiovascular Health and Disease: An Updated Review.
Shrestha S, Harrison I, Dosunmu A, Song P. · · 2026 · PMID 41597225 · DOI 10.3390/cells15020150
Verify or expand the search:
- PubMed search for NCT05236335
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ketone ester
Trials testing the same drug.
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- NCT07087093 — Effects of Ketone Esters on Circulating Senescent T Lymphocytes (T Cells) and Inflammation Levels in the Elderly · NA · recruiting
- NCT06846840 — Ketone Esters and Metabolism During Recovery from Endurance Exercise · NA · active not recruiting
- NCT06097754 — Intermittent Exogenous Ketosis (IEK) at High Altitude · NA · unknown
Other recruiting trials for Heart Failure With Preserved Ejection Fraction
Currently open trials in the same condition.
- NCT06833138 — Atrioventricular Node Ablation and Conduction System Pacing in Patients With Well Controlled Permanent Atrial Fibrillati · NA · recruiting
- NCT06937827 — Transitions of Care Clinic (TOCC) · NA · recruiting
- NCT07037459 — Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity · Phase 3 · recruiting
- NCT06702501 — The PeriCut Catheter System Early Feasibility Study (REIMAGINE-HFpEF) · NA · recruiting
- NCT06616974 — A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction · Phase 2 · recruiting
Other University of Aarhus trials
Trials by the same sponsor.
- NCT07209540 — European LUpuS Inception-Cohort Developing initiATivE · not yet recruiting
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- 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)
- Trial protocol + status: ClinicalTrials.gov NCT05236335 (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: 10 October 2023
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/NCT05236335.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing