Heart Failure, Diastolic
Conditions
Keywords
Exercise, Spermidine
Brief summary
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
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).
Interventions
DIETARY_SUPPLEMENTspermidineLife
dietary supplement that is made of natural wheat germ extract with high spermidine content
DIETARY_SUPPLEMENTPlacebo
dietary supplement that is made of cellulose.
Sponsors
University Medicine Greifswald
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory exercise capacity | 16 weeks | Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diastolic function | 16 weeks | Change in diastolic function based on echocardiography (E/e') |
| Microvascular function | 16 weeks | Reactive hyperemia index assessed using EndoPat |
Other
| Measure | Time frame | Description |
|---|---|---|
| Digit Span test battery for attention testing | 16 weeks | Digit Span test battery for attention testing; from 0 to 8, Score: maximum number of digits that were correctly remembered after 3 erros the test ends. direction of the task (forward or backwards), the longest sequence successfully reached and passed, and the total number of attempts |
| brain magnetic resonance imaging (MRI) - T1 | 16 weeks | brain magnetic resonance imaging (MRI) T1 to assess cortical brain structure pre and post intervention |
| Multiple-Choice Vocabulary Intelligence Test (MWT-B) | 16 weeks | Multiple-Choice Vocabulary Intelligence Test: Measure: total number of correctly checked lines. Final outcome: IQ (standard value and percentile rank) |
| brain magnetic resonance imaging (MRI) - DTI | 16 weeks | brain magnetic resonance imaging (MRI) - DTI to assess fractional anisotropy and fiber tracking pre and post intervention |
| brain magnetic resonance imaging (MRI) - resting state fMRI | 16 weeks | brain magnetic resonance imaging (MRI) resting state fMRI to assess brain network connectivity pre and post intervention |
| brain magnetic resonance imaging (MRI) - FLAIR | 16 weeks | brain magnetic resonance imaging (MRI) - FLAIR to assess white matter hyperintensities pre and post intervention |
| Mnemonic Similarity Task (MST) | 16 weeks | Mnemonic Similarity Task (MST). % of correctly answered tasks (0 - 100 %). final outcome: D - Prime |
| Verbal Learning and Memory Test (VLMT) | 16 weeks | Verbal Learning and Memory Test (VLMT) % of correctly answered tasks (0 - 100 %). final outcome: D - Prime |
Countries
Germany
Contacts
Primary ContactMarcus Dörr, MD
Backup ContactMartin Bahls, PhD
Outcome results
None listed