Weight-Adjusted Dosing of 3-OHB in Patients With Chronic Heart Failure

NCT ID: NCT04594265

Last Updated: 2022-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2022-09-30

Brief Summary

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We aim to investigate the hemodynamic effects of weight-adjusted dosing of ketone monoester en patients with chronic heart failure.

Detailed Description

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Conditions

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Heart Failure Ketosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Patients are studied in a randomized single-blind cross-over design.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Ketone Monoester

Weight-adjusted dose of 3-OHB Monoester (KetoneAID KE4, Virginia, US) 0.5 g/kg (max 50 g)

Group Type EXPERIMENTAL

KetoneAid KE4 Pro Monoester

Intervention Type DIETARY_SUPPLEMENT

A dietary supplement containing ketone monoester.

Placebo Treatment

Maltodextrin-based placebo (Science In Sport, UK) in isocaloric dose to the experimental arm.

Group Type PLACEBO_COMPARATOR

Science in Sport Go Enegy

Intervention Type DIETARY_SUPPLEMENT

Dosis isocaloric to the KetoneAid Arm

Ketone Monoester in presence of low-dose insulin clamp

Same as experimental arm, but in the presence of a low-dose insulin clamp to suppress free fatty acid metabolism

Group Type ACTIVE_COMPARATOR

KetoneAid KE4 Pro Monoester

Intervention Type DIETARY_SUPPLEMENT

A dietary supplement containing ketone monoester.

Interventions

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KetoneAid KE4 Pro Monoester

A dietary supplement containing ketone monoester.

Intervention Type DIETARY_SUPPLEMENT

Science in Sport Go Enegy

Dosis isocaloric to the KetoneAid Arm

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

Inclusion criteria: Chronic HF: NYHA class II-III, left ventricular ejection fraction (LVEF) \<40%

Exclusion Criteria: Diabetes or HbA1c \>48 mmol/mol, significant cardiac valve disease, severe stable angina pectoris, severe comorbidity as judged by the investigator, inability to give informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Kristian Hylleberg Christensen

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kristian H Christensen, MD

Role: CONTACT

+4578452029

Henrik S Wiggers, DMsci

Role: CONTACT

Facility Contacts

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Kristian H Christensen, MD

Role: primary

Other Identifiers

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KETO-KINETICS 2 1-10-72-23-20

Identifier Type: -

Identifier Source: org_study_id

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