Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic He… (NCT05348460) | Clinical Trial Compass
CompletedNot Applicable
Effects of a Single Oral Dose of KETone Ester ON Exercise Performance in Patients With Chronic Heart Failure
Netherlands15 participantsStarted 2022-02-15
Plain-language 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), or a taste matched, isovolumic placebodrink and will then perform the 31phosphorus Magnetic Resonance Spectroscopy (31P MRS) exercise protocol. After 1-2 weeks, subjects will cross-over and repeat the 31P MRS exercise protocol, this time receiving the other treatment.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Chronic Heart Failure NYHA II - III
* LVEF ≤40%
* Stable for the last 1 month prior to the study
Exclusion Criteria:
* 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.
What they're measuring
1
Phosphocreatine (PCr) and inorganic phosphate (Pi) concentrations from baseline to maximum exercise