Last reviewed · How we verify
NCT04942548
Reverse HFpEF: Ketogenic Reversal of Heart Failure With Preserved Ejection Fraction Study
NA trial testing Ketogenic Diet in Heart Failure in 16 participants. Completed in 24 July 2023.
24 July 2023
Quick facts
| Lead sponsor | National Jewish Health |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 16 |
| Start date | 25 July 2019 |
| Primary completion | 24 July 2023 |
| Estimated completion | 24 July 2023 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Ketogenic Diet — full drug profile →
Conditions studied
- Heart Failure — all drugs for Heart Failure →
Sponsor
National Jewish Health — full company profile →
Who can join
Adults 21 to 80, any sex, with Heart Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This protocol is a prospective pilot study utilizing the intervention of a medically supervised, registered nurse and registered diabetes educator coached low-carbohydrate, ketogenic diet to examine the impact it has as a treatment for heart failure with preserved ejection fraction.
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 -
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 -
Cardiac energy substrate utilization in heart failure with preserved ejection fraction: reconciling conflicting evidence on fatty acid and glucose metabolism.
Shehadeh LA, Robleto E, Lopaschuk GD. · · 2025 · cited 14× · PMID 40251758 · DOI 10.1152/ajpheart.00121.2025 -
Ketone bodies in right ventricular failure: A unique therapeutic opportunity.
Blake M, Puchalska P, Kazmirczak F, Blake J, et al · · 2023 · cited 12× · PMID 38058654 · DOI 10.1016/j.heliyon.2023.e22227 -
Nonpharmacological Strategies in Heart Failure with Preserved Ejection Fraction.
Bohmke NJ, Billingsley HE, Kirkman DL, Carbone S. · · 2022 · cited 8× · PMID 36210133 · DOI 10.1016/j.ccl.2022.06.003 -
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 NCT04942548
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ketogenic Diet
Trials testing the same drug.
- NCT07121894 — Ketogenic Intervention for Bipolar Depression · NA · recruiting
- NCT06894004 — Mechanism of Ketogenic Diet-Induced Hypercholesterolemia · NA · recruiting
- NCT06515912 — Ketogenic Diet in Healthy Adults With Differing BMI · NA · completed
- NCT06503809 — Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes · NA · recruiting
- NCT06325644 — Well-Formulated Ketogenic Diet Polycystic Kidney Disease · NA · recruiting
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 National Jewish Health trials
Trials by the same sponsor.
- NCT06435520 — Enhancing Hypnotic Medication Discontinuation in Primary Care · Phase 4 · recruiting
- NCT06262282 — Mycobacteriophage Treatment of Non-tuberculosis Mycobacteria · enrolling by invitation
- NCT06155747 — Transmission and Acquisition of Nontuberculous Mycobacteria Outbreak Investigation (TrANsMIt) · recruiting
- NCT04724278 — Measuring Omalizumab Responses Using Real-world Evidence (MORRE) Study · unknown
- NCT05313087 — COVID-19 Vaccine Response in Chronic Respiratory Conditions · unknown
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 NCT04942548 (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 National Jewish Health
- Last refreshed: 3 April 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/NCT04942548.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing