icotinamide (vitamin B3) – diet and exercise in the context of prolonged outpatient rehabilitation – a randomized, placebo-controlled, double-blind pilot study
Not Applicable
Recruiting
- Conditions
- I25.1Atherosclerotic heart disease
- Registration Number
- DRKS00031318
- Lead Sponsor
- Medizinische Universität Graz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Written declaration of consent from the study participants to participate in the study after detailed explanation of the nature, significance, risks and scope of the study
- Systolic blood pressure >110mmHg
- Outpatient cardiac rehabilitation that has been ongoing for > 3 months
- Stable drug treatment of the underlying cardiac disease
Exclusion Criteria
- Higher grade supraventricular or ventricular arrhythmias
- Renal insufficiency with GFR < 45ml/min
- Insulin dependent diabetes mellitus
- Expected life expectancy < 1 year
- Current participation in another clinical trial
- Taking vitamin supplements containing niacin/vitamin B3
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Quantification of Nicotinamide Adenine Dinucleotide (NAD+) concentration in blood<br><br>The quantification is done using ultra high performance liquid chromatography coupled with mass spectrometry (UHPLC-MS) at baseline and after 8 weeks.
- Secondary Outcome Measures
Name Time Method AD metabolomes in plasma and PBMCs<br>Spiro ergometry: maximum exhaustion level in % of target; maximum exhaustion level in watts; heart rate increase during exercise; maximum heart rate during exercise; VO2max; anaerobic threshold<br>Electrocardiography: Standard analyses<br>Autophagy in PBMCs<br>Immune cell profiles<br>Plasma cytokines<br>