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

Heart Failure, Diastolic Clinical Trial

— PERMIT_EX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05128331
• Other study ID #: PERMIT-HGW-DZHK40
• Status: Recruiting
• Phase: N/A
• Start date: August 11, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: University Medicine Greifswald
• Contact: Marcus Dörr, MD
• Phone: +4938348680500
• Email: marcus.doerr[@]med.uni-greifswald.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Diastolic

Intervention

Dietary Supplement:
• spermidineLife
dietary supplement that is made of natural wheat germ extract with high spermidine content
• Placebo
dietary supplement that is made of cellulose.

Locations

Country	Name	City	State
Germany	Cardiovascular examination center of the University Medicine Greifswald	Greifswald

Sponsors (1)

Lead Sponsor	Collaborator
University Medicine Greifswald

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Multiple-Choice Vocabulary Intelligence Test (MWT-B)	Multiple-Choice Vocabulary Intelligence Test: Measure: total number of correctly checked lines. Final outcome: IQ (standard value and percentile rank)	16 weeks
Other	Mnemonic Similarity Task (MST)	Mnemonic Similarity Task (MST). % of correctly answered tasks (0 - 100 %). final outcome: D - Prime	16 weeks
Other	Verbal Learning and Memory Test (VLMT)	Verbal Learning and Memory Test (VLMT) % of correctly answered tasks (0 - 100 %). final outcome: D - Prime	16 weeks
Other	Digit Span test battery for attention testing	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	16 weeks
Other	brain magnetic resonance imaging (MRI) - T1	brain magnetic resonance imaging (MRI) T1 to assess cortical brain structure pre and post intervention	16 weeks
Other	brain magnetic resonance imaging (MRI) - FLAIR	brain magnetic resonance imaging (MRI) - FLAIR to assess white matter hyperintensities pre and post intervention	16 weeks
Other	brain magnetic resonance imaging (MRI) - DTI	brain magnetic resonance imaging (MRI) - DTI to assess fractional anisotropy and fiber tracking pre and post intervention	16 weeks
Other	brain magnetic resonance imaging (MRI) - resting state fMRI	brain magnetic resonance imaging (MRI) resting state fMRI to assess brain network connectivity pre and post intervention	16 weeks
Primary	Cardiorespiratory exercise capacity	Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training	16 weeks
Secondary	Diastolic function	Change in diastolic function based on echocardiography (E/e')	16 weeks
Secondary	Microvascular function	Reactive hyperemia index assessed using EndoPat	16 weeks