Heart Failure With Reduced Ejection Fraction, Ketosis
Conditions
Keywords
Endogenous ketosis, Exogenous ketosis, Heart failure
Brief summary
This randomized controlled trial will evaluate the effect of a ketogenic diet and/or exogenous administration of ketone bodies vs conventional diet on the ejection fraction of patients with non-ischemic chronic heart failure, measuring MRI biomarkers.
Detailed description
Evidence in both animals and humans suggests ketosis could be beneficial for people living with chronic heart failure. To date, no study has compared endogenous vs exogenous ketosis in patients with chronic heart failure. We will randomize (with a 1:1:1 ratio) patients with a confirmed diagnosis of non-ischemic chronic heart failure to undergo one of the following: 1. \- A ketogenic diet (\<50 gr of carbohydrates per day) incorporating current recommendations for heart failure (low sodium and liquids) for 10 days. 2. \- Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days. 3. \- Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo. The endpoints will be assessed using cardiac MRI and blood biomarkers.
Interventions
BEHAVIORALKetogenic diet
A diet with \<50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats
DIETARY_SUPPLEMENTExogenous ketones
Administration of ketone monoester 25 ml t.i.d
BEHAVIORALStandard diet + placebo
A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.
Sponsors
University of Oxford
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ejection fraction \<40% minimum 1 month. * No change in optimum treatment 1 month at least.
Exclusion criteria
* Ischemic cardiopathy (Angio-tomography corroborated cut-point \>50% obstruction, coronary angiography, or cardiac scintigraphy 6 months at least) or angina pectoris symptoms. * Reynaud syndrome * Metformin or SGLT-2 Inhibitors treatment, Low BMI, nutritional deficiencies. * Creatinin clearance \<30ml/min or renal replacement therapy * MRI contraindications (prothesis, Unsupported pacemakers, claustrophobia, etc) * Reynaud phenomenon history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ejection fraction Improvement | 10 days | Estimated by cardiac MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical severity | 10 days | Estimated with the NYHA classification |
| Liquid retention | 10 days | Estimated by electric bioimpedance |
| Blood biomarker | 10 days | BNP |
Countries
Mexico
Contacts
Primary ContactAdrian Soto, Ph.D, MD.
Backup ContactJorge Oseguera, MD
Outcome results
None listed