Status:
COMPLETED
Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
Netherlands Heart Foundation
Conditions:
Heart Failure With Reduced Ejection Fraction
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In a randomized, double-blind, placebo-controlled cross-over design, subjects will either receive a supplemental drink containing a commercially available ketone ester (DeltaG®, 500 mg/kg body weight)...
Detailed Description
The goal of this study is to investigate if oral ketone supplementation stimulates mitochondrial ATP production and improves exercise performance in patients with chronic HF. In a randomized, double-b...
Eligibility Criteria
Inclusion
- Chronic Heart Failure NYHA II - III
- LVEF ≤40%
- Stable for the last 1 month prior to the study
Exclusion
- Age \<18 years;
- Unable or unwilling to undergo exercise MRI (physical disabilities, claustrophobia);
- Unable to complete the exercise protocol during the screening visit according to the professional opinion of the investigators;
- Comorbidities which can influence study results such as muscular dystrophies, peripheral artery disease, diabetes mellitus, severe anaemia (defined as Hb ≤6 mmol/L);
- Pregnant/trying to get pregnant/breastfeeding during the period from the first exercise test until 4 weeks after the last exercise test);
- Absolute contra-indications to undergo MRI according to the current UMCG protocols and guidelines (e.g. non-conditional medical device, recent device implantation, incompatible ferromagnetic objects in the body).
- BMI \< 16 kg/m2; BMI \> 35 kg/m2
- Unable to understand study procedures;
- Unable or unwilling to provide informed consent.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05348460
Start Date
February 15 2022
End Date
July 1 2023
Last Update
May 3 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ