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

October 17, 2022 updated by: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Cdmx
      • Mexico City, Cdmx, Mexico, 14080

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Diet
Standard diet incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with bitter taste placebo.
Behavioral: Standard diet + placebo
A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.
Experimental: Endogenous Ketosis
Ketogenic diet incorporating current recommendations for heart failure (<50gr of carbohydrates, low sodium, and liquids) for 10 days.
Behavioral: Ketogenic diet
A diet with <50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats
Experimental: Exogenous ketosis
Standard incorporating current recommendations for heart failure (low sodium and liquids) and supplementation with exogenous ketones (ketone monoester) for 10 days.
Dietary supplement: Exogenous ketones
Administration of ketone monoester 25 ml t.i.d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ejection fraction Improvement
Time Frame: 10 days
Estimated by cardiac MRI
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical severity
Time Frame: 10 days
Estimated with the NYHA classification
10 days
Liquid retention
Time Frame: 10 days
Estimated by electric bioimpedance
10 days
Blood biomarker
Time Frame: 10 days
BNP
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Collaborators

University of Oxford

Investigators

  • Principal Investigator: Adrian Soto, Ph.D, MD., INCMNSZ

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

October 20, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 10, 2021

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 17, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIE-3652-21-22-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Upon request to PI

IPD Sharing Time Frame

One year after publication

IPD Sharing Access Criteria

Send email to adrian.sotom@incmnsz.mx

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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