Clinical trial NCT04921293: Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction
Official title: Comparison Between Endogenous and Exogenous Ketosis in Patients With Non-ischemic Chronic Heart Failure With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure With Reduced Ejection Fraction
Ketosis
Keywords: Endogenous ketosis
Exogenous ketosis
Heart failure
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2021-06-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Ejection fraction Improvement
timeFrame: 10 days
Secondary outcomes:
measure: Clinical severity
timeFrame: 10 days
measure: Liquid retention
timeFrame: 10 days
measure: Blood biomarker
timeFrame: 10 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: INCMNSZ
state: Cdmx
Study officials:
affiliation: INCMNSZ
name: Adrian Soto, Ph.D, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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