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NCT05348460: KETONE-HF
Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure
NA trial testing Ketone ester drink (DeltaG®, 500 mg/kg body weight) in Heart Failure With Reduced Ejection Fraction in 15 participants. Completed in 1 July 2023.
1 July 2023
Quick facts
| Lead sponsor | University Medical Center Groningen |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 15 |
| Start date | 15 February 2022 |
| Primary completion | 1 July 2023 |
| Estimated completion | 1 July 2023 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- Ketone ester drink (DeltaG®, 500 mg/kg body weight)
- Taste-matched, isovolumic placebo drink
Conditions studied
- Heart Failure With Reduced Ejection Fraction — all drugs for Heart Failure With Reduced Ejection Fraction →
- Heart Failure — all drugs for Heart Failure →
Sponsor
University Medical Center Groningen
Who can join
18 and older, any sex, with Heart Failure With Reduced Ejection Fraction or Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
Publications & conference data
6 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 -
Aging in Heart Failure: Embracing Biology Over Chronology: JACC Family Series.
Goyal P, Maurer MS, Roh J. · · 2024 · cited 27× · PMID 38597865 · DOI 10.1016/j.jchf.2024.02.021 -
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 -
Therapeutic potential of ketone bodies on exercise intolerance in heart failure: looking beyond the heart.
Soni S, Skow RJ, Foulkes S, Haykowsky MJ, et al · · 2025 · cited 4× · PMID 39825790 · DOI 10.1093/cvr/cvaf004 -
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:
- PubMed search for NCT05348460
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other University Medical Center Groningen trials
Trials by the same sponsor.
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- NCT07527390 — CANagliflozin In DIALysis Patients · Phase 4 · not yet recruiting
- NCT07439237 — Implant-supported Maxillary Overdentures; a 15-years Evaluation · not yet recruiting
- NCT07275437 — Effectiveness and Safety of Uptitration of Guideline Directed MEdical Therapy in Heart Failure With Reduced Ejection Fra · 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 NCT05348460 (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 Medical Center Groningen
- Last refreshed: 3 May 2024
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/NCT05348460.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing