Clinical trial NCT05128331: sPERMIdine supplemenTation on Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING
Official title: The Effect of sPERMIdine supplemenTation on the Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING in Patients With Heart Failure With Preserved Ejection Fraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure, Diastolic
Keywords: Exercise
Spermidine
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Cardiorespiratory exercise capacity
timeFrame: 16 weeks
Secondary outcomes:
measure: Diastolic function
timeFrame: 16 weeks
measure: Microvascular function
timeFrame: 16 weeks
Other outcomes:
measure: Multiple-Choice Vocabulary Intelligence Test (MWT-B)
timeFrame: 16 weeks
measure: Mnemonic Similarity Task (MST)
timeFrame: 16 weeks
measure: Verbal Learning and Memory Test (VLMT)
timeFrame: 16 weeks
measure: Digit Span test battery for attention testing
timeFrame: 16 weeks
measure: brain magnetic resonance imaging (MRI) - T1
timeFrame: 16 weeks
measure: brain magnetic resonance imaging (MRI) - FLAIR
timeFrame: 16 weeks
measure: brain magnetic resonance imaging (MRI) - DTI
timeFrame: 16 weeks
measure: brain magnetic resonance imaging (MRI) - resting state fMRI
timeFrame: 16 weeks
Locations:
city: Greifswald
country: Germany
facility: Cardiovascular examination center of the University Medicine Greifswald
Study officials:
References: