sPERMIdine supplemenTation on Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING

Study Overview
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Brief Summary
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This study explores whether spermidine supplementation improves the metabolic, neurological-cognitive and cardiovascular response to structured exercise training in patients with heart failure with preserved ejection fraction. The investigators aim to show that a faster adaptation to exercise may improve long term adherence to a more active lifestyle.

Detailed Description
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Heart failure with preserved ejection fraction is the largest unmet need in medicine. Exercise training is a pivotal lifestyle intervention which has been shown to have beneficial effects with regards to metabolic, neurological-cognitive and cardiovascular outcomes in these patients. Yet, not every patients responds equally fast to an exercise training intervention. This trial explores whether the supplementation of spermidine can increase the response to a structured aerobic exercise training. The investigators will recruit 30 patients who will either receive a spermidine supplement or a placebo. The study participants are invited for a first follow-up visit after four weeks. The exercise intervention starts at week 5 and continues for 12 weeks. Hence, overall there are three visits (baseline, week four and week twelve).

Official Title
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The Effect of sPERMIdine supplemenTation on the Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING in Patients With Heart Failure With Preserved Ejection Fraction

Conditions
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Heart Failure, Diastolic

Intervention / Treatment
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* Dietary Supplement: spermidineLife
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diastolic heart failure (E/e' > 8, left ventricular ejection fraction (LVEF) => 50 %, dyspnea) Exclusion Criteria: nutritional supplements with polyamines acute myo-, endo- or pericarditis aortic valve stenosis (2nd degree) cardiomyopathy or severe left ventricular hypertrophy (Interventricular septal end diastolic thickness or posterior wall thickness > 17 mm) AV block (second degree) pulmonary hypertension thromboembolic event in the last six months anemia infection (with fever) within the last four weeks cancer

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spermidine supplementation<br>Study participants are provided with spermidine supplementation | Dietary Supplement: spermidineLife<br>* dietary supplement that is made of natural wheat germ extract with high spermidine content<br>|
| Placebo Comparator: Placebo supplementation<br>Study participants are provided with a placebo supplementation | Dietary Supplement: Placebo<br>* dietary supplement that is made of cellulose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory exercise capacity | Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic function | Change in diastolic function based on echocardiography (E/e') | 16 weeks | 
| Microvascular function | Reactive hyperemia index assessed using EndoPat | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Spermidine