Heart Failure, DiastolicPERMIT_EXNCT05128331
sPERMIdine supplemenTation on Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING
A study testing spermidineLife in people with Heart Failure, Diastolic, run by University Medicine Greifswald at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Heart Failure, Diastolic
- What is being tested?
- spermidineLife
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 11 Aug 2021to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diastolic heart failure (E/e' > 8, left ventricular ejection fraction (LVEF) => 50 %, dyspnea)
Who cannot join
- 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
Show all 10Show fewer
- thromboembolic event in the last six months
- anemia
- infection (with fever) within the last four weeks
- cancer
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Cardiovascular examination center of the University Medicine Greifswald
Greifswald, 17489
Martin Bahls, Ph.D., +49 3834 8680500, martin.bahls@uni-greifswald.de
About this study
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
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.
Read the 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).
- Conditions
- Heart Failure, Diastolic
- Being tested
- spermidineLife, Placebo
- Keywords
- Exercise, Spermidine
- Medical subject headings
- Heart Failure, Diastolic, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spermidineLifeDietary supplement
dietary supplement that is made of natural wheat germ extract with high spermidine content
PlaceboDietary supplement
dietary supplement that is made of cellulose.
| Study group | Role | What they receive |
|---|---|---|
| Spermidine supplementation | Experimental | Study participants are provided with spermidine supplementation Receives: Dietary Supplement: spermidineLife |
| Placebo supplementation | Placebo comparator | Study participants are provided with a placebo supplementation Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiorespiratory exercise capacity
Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training
Measured: 16 weeks
Secondary outcomes (2)
Diastolic function
Change in diastolic function based on echocardiography (E/e')
Measured: 16 weeks
Microvascular function
Reactive hyperemia index assessed using EndoPat
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start11 Aug 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medicine Greifswald
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128331
- Sponsor's protocol ID
- PERMIT-HGW-DZHK40
- Acronym
- PERMIT_EX
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Our ethics approval does not allow to share IPD for this trial.
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05128331
- Acronym / sponsor ID
- PERMIT_EX / PERMIT-HGW-DZHK40
- Conditions
- Heart Failure, Diastolic
- Keywords
- Exercise, Spermidine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Medicine GreifswaldUniversity, hospital or other
- Study start
- 11 Aug 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spermidine supplementation | Experimental | Dietary Supplement: spermidineLifeStudy participants are provided with spermidine supplementation |
| Placebo supplementation | Placebo comparator | Dietary Supplement: PlaceboStudy participants are provided with a placebo supplementation |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diastolic heart failure (E/e' > 8, left ventricular ejection fraction (LVEF) => 50 %, dyspnea)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| spermidineLifedietary supplement that is made of natural wheat germ extract with high spermidine content | Dietary supplement | Spermidine supplementation |
| Placebodietary supplement that is made of cellulose. | Dietary supplement | Placebo supplementation |
Primary outcome
Cardiorespiratory exercise capacity
Time frame: 16 weeks
Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training
2 secondary outcomes
Diastolic function
Time frame: 16 weeks
Microvascular function
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: No. Our ethics approval does not allow to share IPD for this trial.
Related trials for Heart Failure, Diastolic
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spermidineLife in people with Heart Failure, Diastolic, run by University Medicine Greifswald at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcus Dörr, MD (+4938348680500, marcus.doerr@med.uni-greifswald.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiorespiratory exercise capacity (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.