Exogenous Ketones for Acutely Decompensated HEart Failure

NCT04698005 | Unknown Phase 3

• 1 other identifier: A-20-28
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate whether supplementation of exogenous ketones in patients with severe left ventricular dysfunction and acutely decompensated heart failure requiring inotropic therapy would improve the patient's hemodynamics and symptoms.

Conditions

Acute Heart Failure; Low Cardiac Output Syndrome; Hemodynamic Instability; Ketosis

Outcome Measures

Primary Outcomes (4)

• Maximum change of stroke volume index

  Maximum change of stroke volume index (ml/m2) between baseline and hour 1 - 3

  Maximum value of stroke volume index measured between hour 1 - 3 of the study protocol at 15-minute intervals

• Maximum change of cardiac index

  Maximum change of cardiac index (L/m2) between baseline and hour 1 - 3

  Maximum value of cardiac index measured between hour 1 - 3 of the study protocol at 15-minute intervals

• Change of mean stroke volume index

  Difference between baseline stroke volume index and mean stroke volume index (ml/m2) during the study protocol

  Mean value of stroke volume index measured every 15 minutes during 9 hours of the study protocol

• Change of mean cardiac index

  Difference between baseline cardiac index (L/m2) and mean cardiac index during the study protocol

  Mean value of cardiac index measured every 15 minutes during 9 hours of the study protocol

Secondary Outcomes (1)

• Change in patient/symptoms

  Symptoms scored at hours 0, 1, 10, 24 and expressed as an area under the curve

Study Arms (2)

Supplementation of exogenous ketones

EXPERIMENTAL

Exogeneous ketones will be administered orally using monoester 3-OHB concentrate without added salts (25g 3-OHB in 65ml H.V.M.N Ketone Ester, H.V.M.N, USA or equivalent). The drink will be administered over 10 mins every 3 hours, 3 times in a row.

Dietary Supplement: 25g Ketone monoester without added salts

Control group

PLACEBO COMPARATOR

The patients will receive a placebo drink (drinking water) of equivalent volume (3x 65ml)

Other: Placebo

Interventions

25g Ketone monoester without added salts DIETARY_SUPPLEMENT

oral supplementation of ketone monoester

Also known as: 25g 3-OHB in 65ml, H.V.M.N Ketone Ester, H.V.M.N, USA or equivalent

Supplementation of exogenous ketones

Placebo OTHER

The patients will receive a placebo drink (drinking water) of equivalent volume (3x 65ml)

Control group

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 due ischemic or nonischemic cardiomyopathy
• Acute decompensation of heart failure with the need of inotropes
• Achievement of relative stabilization on inotropes (INTERMACS class \>2)
• Left ventricular ejection fraction \<= 35%
• Age \>18 years

You may not qualify if:

• Deteriorating cardiogenic shock with likely need of mechanical circulatory support in the subsequent 48 hours
• Chronic kidney disease grade 4 or 5
• Diabetic ketoacidosis (3-OHB \>2mmol/l at baseline)
• Hemodynamic severe arrhythmias
• Acute heart failure due to transient triggers (acute coronary syndrome, atrial fibrillation, infection etc..)
• Contraindications to invasive hemodynamic monitoring

Sponsors & Collaborators

• Institute for Clinical and Experimental Medicine: lead

Study Sites (1)

Institute for Clinical and Experimental Medicine (IKEM)

Prague, 14059, Czechia

RECRUITING

MeSH Terms

Conditions

Cardiac Output, Low; Ketosis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Marek Sramko, MD, PhD

CONTACT

+420776246127; marek.sramko@ikem.cz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The participant and the physician in charge of the participant will be blinded to the given treatment (ketone drink vs. placebo)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Acute Cardiology

Model Details: randomisation 1:1 to active treatment (exogenous ketones) vs. placebo (drinking water of equivalent volume)

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: January 6, 2021
• Study Start: December 2, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

CZ (1)