Effects of a single oral dose of Ketone ester ON Exercise performance in patients with chronic Heart Failure

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

HFrEF
- Chronic Heart Failure NYHA II - III
- LVEF<=40%
- Stable for the last 1 months prior to the study

HFpEF
- Chronic Heart Failure NYHA II - III
- HFpEF based on HFaPEFF score >= 5
- LVEF >= 45 %
- Stable for the last 1 month prior to the study

Exclusion Criteria

HFrEF
- Age <18 years;
- Unable or unwilling to undergo exercise MRI (physical disabilities,
claustrophobia);
- VO2peak >80% of expected and or/a cycling time of <8 minutes on recent
exercise testing;
- Comorbidities which can influence study results such as muscular dystrophies,
peripheral artery disease, insulin dependent 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 > 40 kg/m2;
- Unable to understand study procedures;
- Unable or unwilling to provide informed consent.

HFpEF
- Age <18 years;
- Unable or unwilling to undergo exercise MRI (physical disabilities,
claustrophobia);
- VO2peak >80% of expected and or/a cycling time of <8 minutes on recent
exercise testing;
- Comorbidities which can influence study results such as muscular dystrophies,
peripheral artery disease, insulin dependent diabetes mellitus, severe anaemia
(defined as Hb <=6 mmol/L), hypertrophic cardiomyopathy with outflow tract
obstruction and/or moderate to severe heart valve disease;
- 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 > 40 kg/m2
- Estimated glomular filtration rate <30
- Unable to understand study procedures;
- Unable or unwilling to provide informed consent.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Rate and magnitude of change in PCr and Pi concentrations from baseline to<br /><br>maximum exercise. These parameters inform on the integrated homeostatic<br /><br>performance of oxidative and glycolytic ATP synthetic networks in muscle during<br /><br>exercise.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Post-exercise recovery rate of PCr and Pi concentrations. These rates inform<br /><br>on mitochondrial ATP synthetic function<br /><br>- Rates and magnitude of change in intramuscular pH during exercise and<br /><br>recovery. These parameters inform on the magnitude of anaerobic, glycolytic ATP<br /><br>synthesis.<br /><br>- Maximal exercise performance. </p><br>