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

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status: Enrolling

Conditions: Ketosis; Heart Failure With Reduced Ejection Fraction

Treatments: Behavioral: Standard diet + placebo; Behavioral: Ketogenic diet; Dietary Supplement: Exogenous ketones

Study type: Interventional

Funder types: Other

Identifiers

NCT04921293

UIE-3652-21-22-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

18 participants in 3 patient groups

Standard Diet

Active Comparator group

Description:

Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.

Treatment:

Behavioral: Standard diet + placebo

Endogenous Ketosis

Experimental group

Description:

Ketogenic diet incorporating current recommendations for heart failure (\<50gr of carbohydrates, low sodium, and liquids) for 10 days.

Treatment:

Behavioral: Ketogenic diet

Exogenous ketosis

Experimental group

Description:

Standard incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.

Treatment:

Dietary Supplement: Exogenous ketones