Nutritional Ketosis in Heart Failure

NCT04370600 | Unknown Phase 1

• 1 other identifier: JT#15471
• Study Type: interventional
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Chronic, ambulatory heart failure patients will be given ketone ester dietary supplementation to determine therapeutic efficacy, metabolic adaptation, pharmacokinetics, associated cognitive changes, and safety within this patient cohort in order to establish preliminary data to later conduct a multi-center randomized clinical trial.

Conditions

Chronic Heart Failure

Keywords

ketosis; beta-hydroxybutyrate; insulin; bioenergetics; exercise tolerance; metabolic; diabetes

Outcome Measures

Primary Outcomes (7)

• BHB Concentration in blood

  Beta-hydroxybutyrate concentration in blood

  1 Year

• Minutes at maximum exertion [Exercise Capacity]

  Minutes at maximum exertion

  1 Year

• Left ventricular ejection fraction (%)

  Left ventricular ejection fraction, measured by echocardiogram

  1 Year

• Cardiac output (L/min)

  Cardiac output, measured by echocardiogram

  1 Year

• Left ventricular end diastolic diameter (LVEDD) (cm)

  LVEDD, measured by echocardiogram

  1 Year

• Insulin concentration

  Insulin concentration in blood

  1 Year

• Bicarbonate concentration

  Bicarbonate concentration in blood

  1 Year

Study Arms (2)

Group A

ACTIVE COMPARATOR

These patients will receive ketone supplementation between visits 1 and 2 and will receive placebo drink between visits 2 and 3 (after the washout period).

Drug: beta hydroxybutyrate (BHB) ester; Drug: Placebo

Group B

ACTIVE COMPARATOR

These patients will receive ketone supplementation between visits 2 and 3 (after the washout period) and will receive placebo drink between visits 1 and 2

Drug: beta hydroxybutyrate (BHB) ester; Drug: Placebo

Interventions

beta hydroxybutyrate (BHB) ester DRUG

Ketone supplementation given 3x/day (60mL per dose, or 22g BHB)

Also known as: Delta G

Group A; Group B

Placebo DRUG

Denatonium benzoate + HVMN ketone placebo flavor mix + Stevia

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Equal to or greater than 18 years of age
• Diagnosis of heart failure and be classified as NYHA Class II or III either pre-enrollment or at the time of enrollment
• Stable medical therapy for at least 1 month prior to enrollment
• Taking appropriate daily cardiac medications as determined by the principal investigator, who is a heart failure specialist

You may not qualify if:

• Atrial fibrillation
• Inability to exercise on a supine bicycle.
• Moderate or greater valvular disease.
• Hemoglobin \<10 g/dL.
• Daily insulin use
• Hypertrophic, infiltrative, or inflammatory cardiomyopathy.
• Pericardial disease.
• Current angina due to clinically significant obstructive epicardial coronary disease
• Acute coronary syndrome or coronary intervention within the past 2 months.
• Primary pulmonary arteriopathy.
• Known clinically significant lung disease defined as:
• Current use of supplemental oxygen, aside from nocturnal O2 for the treatment of obstructive sleep apnea
• The use of steroids/antibiotics within the past 6 months for an acute exacerbation of obstructive pulmonary disease
• Most proximal pulmonary function test indicating severe obstructive disease, defined as an FEV1\<50% predicted in the context of an FEV1/FVC ratio of \<0.70 ("Stage III COPD according to GOLD Criteria). (note: only to be used if the subject had PFTs prior to screening)
• Most proximal 6-minute walk test during which the subject experienced arterial desaturation (\<94%) without a subsequent normal study.

Sponsors & Collaborators

• Thomas Jefferson University: lead

MeSH Terms

Conditions

Ketosis; Insulin Resistance; Diabetes Mellitus

Interventions

3-Hydroxybutyric Acid; Esters

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxybutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Ketone Bodies; Ketones; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• J. Eduardo Rame, M.D.

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael W Foster, M.D.

CONTACT

6107160962; mfoster610@gmail.com

Melissa McCarey

CONTACT

2155037417; melissa.mccarey@jefferson.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biological drug + placebo (Group A) or placebo + biological drug (Group B)

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: May 1, 2020
• Study Start: June 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: May 1, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share