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NCT06081543
Ketogenic Diet vs Mixed Diet in Patients With Heart Failure
NA trial testing Ketogenic diet in Heart Failure With Preserved Ejection Fraction in 90 participants. Currently enrolling.
31 August 2026
Quick facts
| Lead sponsor | Ohio State University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 90 |
| Start date | 19 May 2023 |
| Primary completion | 31 August 2026 |
| Estimated completion | 31 August 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ketogenic diet — full drug profile →
- Low-fat Mixed diet
Conditions studied
- Heart Failure With Preserved Ejection Fraction — all drugs for Heart Failure With Preserved Ejection Fraction →
Sponsor
Ohio State University
Who can join
Adults 18 to 80, any sex, with Heart Failure With Preserved Ejection Fraction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study is being done to evaluate the effects of a low carbohydrate ketogenic diet (KD) versus a low-fat diet (MD) on exercise tolerance in participants with heart failure with normal pumping function and diabetes or pre-diabetes, or metabolic syndrome, or obesity.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Lifestyle interventions in cardiometabolic HFpEF: dietary and exercise modalities.
Vacca A, Wang R, Nambiar N, Capone F, et al · · 2025 · cited 17× · PMID 39283525 · DOI 10.1007/s10741-024-10439-1 -
Ketone body metabolism and cardiometabolic implications for cognitive health.
Fulghum K, Salathe SF, Davis X, Thyfault JP, et al · · 2024 · cited 11× · PMID 40093558 · DOI 10.1038/s44324-024-00029-y -
Dietary Interventions in Heart Failure With Preserved Ejection Fraction: A Scoping Review.
Billingsley HE, Carbone S, Driggin E, Kitzman DW, et al · · 2025 · cited 8× · PMID 39801812 · DOI 10.1016/j.jacadv.2024.101465 -
Therapeutic Ketosis for Heart Failure: A State-of-the-Art Review.
Kodur N, Nguyen C, Tang WHW. · · 2025 · cited 5× · PMID 40043832 · DOI 10.1016/j.cardfail.2025.01.028
Verify or expand the search:
- PubMed search for NCT06081543
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07479095 — Low-glucose/High-fat Intake Dietary Regimen as a Tool for Empowering Diagnostic Accuracy of 2-[18F]FDG PET/CT in Lepidic · NA · recruiting
- NCT06963437 — Interventions for Weight Regain After Bariatric Surgery · NA · completed
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 Ohio State University trials
Trials by the same sponsor.
- NCT06542458 — Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog · not yet recruiting
- NCT07217548 — Solving Stigma Through POV Simulation: Enhancing Pharmacist Empathy-based Practices With Sickle Cell Disease Patients · NA · enrolling by invitation
- NCT07215221 — Implementation of TBI-RECOVER in Substance Use Treatment · NA · not yet recruiting
- NCT07278427 — Reducing Parental Substance Use and Enhancing Family Resilience Among Rural Families Through Ohio START · recruiting
- NCT07490444 — Metric-Optimized Spectacle Prescriptions for Children With Down Syndrome · Phase 2 · 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 NCT06081543 (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 Ohio State University
- Last refreshed: 3 April 2025
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/NCT06081543.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing