Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction

Not Applicable

Recruiting

• Conditions: Heart Failure With Reduced Ejection Fraction; Ketosis
• Interventions: Behavioral: Standard diet + placebo; Behavioral: Ketogenic diet; Dietary Supplement: Exogenous ketones

• Registration Number: NCT04921293
• Lead Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Study Timeline

• Study First Submitted: 2021-06-02
• Study First Submitted QC: 2021-06-02
• Study First Posted: 2021-06-10
• Status Verified: 2022-04
• Last Update Submitted: 2022-10-17
• Last Update Posted: 2022-10-18
• Study Start: 2023-06-01
• Primary Completion: 2024-10-20
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Diet	Standard diet + placebo	Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.
Endogenous Ketosis	Ketogenic diet	Ketogenic diet incorporating current recommendations for heart failure (\<50gr of carbohydrates, low sodium, and liquids) for 10 days.
Exogenous ketosis	Exogenous ketones	Standard incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.

Primary Outcome Measures

Name	Time	Method
Ejection fraction Improvement	10 days	Estimated by cardiac MRI

Secondary Outcome Measures

Name	Time	Method
Liquid retention	10 days	Estimated by electric bioimpedance
Blood biomarker	10 days	BNP
Clinical severity	10 days	Estimated with the NYHA classification

Trial Locations

Locations (1)

INCMNSZ; 🇲🇽 Mexico City, Cdmx, Mexico