Modulation of Circulating Levels of the Ketone Body 3-hydroxybutyrate in Patients With Chronic Heart Failure: Cardiovascular Effects

NCT04443426 | Unknown Phase 2

• 1 other identifier: KETO- CHF 1-10-72-362-18
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The ketone body 3-hydroxybutyrate (3-OHB) is a naturally occurring energy substrate, and is associated with increased life span and improved health. We have previously shown that intravenous 3-OHB treatment increases myocardial blood flow \> 70% in healthy humans and data from our group show that 3-OHB increases cardiac output by 40 % in patients with heart failure. In this study the investigators aim to investigate:

1. 1.If this effect is reproducible with a commercially available oral ketone supplements
2. 2.The safety of commercially available ketone supplements in heart failure patients

Conditions

Heart Failure; Ketosis; Ketonemia

Keywords

Metabolism

Outcome Measures

Primary Outcomes (1)

• Cardiac Output (L/min)

  Right Heart Catherization

  5 hours - Area under the curve

Secondary Outcomes (2)

• Left Ventricle Ejection Fraction (%)

  5 Hours - Area under the curve

• Left Ventricular filling pressure (mmHg)

  5 hours - Area under the curve

Study Arms (3)

Single dose oral 3-hydroxybutyrate monoester

EXPERIMENTAL

Cross-over study in 8 patients receiving single-dose oral 3-hydroxybutyrate monoester, 3-OHB salt and placebo.

Dietary Supplement: Ketone Monoester

Single dose oral 3-hydroxybutyrate Salt

EXPERIMENTAL

Dietary Supplement: Oral 3-hydroxybutyrate salts

Single dose oral placebo

PLACEBO COMPARATOR

maltodextrin-based, isocaloric to ketone dosis.

Dietary Supplement: Carbohydrate Placebo

Interventions

Oral 3-hydroxybutyrate salts DIETARY_SUPPLEMENT

Comercially available 3-hydroxybutyrate salts with 36 grams of 3-OHB salts three times daily.

Single dose oral 3-hydroxybutyrate Salt

Carbohydrate Placebo DIETARY_SUPPLEMENT

Comercially available carbohydrate sports drink. The placebo dose is isocaloric to the 3-hydroxy butyrate dose.

Single dose oral placebo

Ketone Monoester DIETARY_SUPPLEMENT

Commercially available ketone monoester in a dosage isocaloric to 3-OHB salts.

Single dose oral 3-hydroxybutyrate monoester

Eligibility Criteria

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

You may qualify if:

• Chronic Heart Failure;
• NYHA class II-III
• Left Ventricular Ejection Fraction \<40%

You may not qualify if:

• Diabetes or HbA1c \> 48 mmol/mol
• Significant cardiac valve disease,
• Severe stable angina pectoris
• Severe comorbidity as judged by investigator,
• Inability to give informed consent.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Heart Failure; Ketosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Kristian H Christensen, MD

  Aarhus Universitetshospital - Department of Cardiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: June 23, 2020
• Study Start: April 25, 2019
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

DK (1)