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

Primary Purpose

Heart Failure, Diastolic

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
spermidineLife
Placebo
Sponsored by
University Medicine Greifswald
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Diastolic focused on measuring Exercise, Spermidine

Eligibility Criteria

50 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cardiovascular examination center of the University Medicine GreifswaldRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Spermidine supplementation

Placebo supplementation

Arm Description

Study participants are provided with spermidine supplementation

Study participants are provided with a placebo supplementation

Outcomes

Primary Outcome Measures

Cardiorespiratory exercise capacity
Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training

Secondary Outcome Measures

Diastolic function
Change in diastolic function based on echocardiography (E/e')
Microvascular function
Reactive hyperemia index assessed using EndoPat

Full Information

First Posted
September 16, 2021
Last Updated
May 18, 2022
Sponsor
University Medicine Greifswald
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1. Study Identification

Unique Protocol Identification Number
NCT05128331
Brief Title
sPERMIdine supplemenTation on Metabolic, Neuronal and Cardiovascular Response to Exercise TRAINING
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 11, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Medicine Greifswald

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Diastolic
Keywords
Exercise, Spermidine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spermidine supplementation
Arm Type
Experimental
Arm Description
Study participants are provided with spermidine supplementation
Arm Title
Placebo supplementation
Arm Type
Placebo Comparator
Arm Description
Study participants are provided with a placebo supplementation
Intervention Type
Dietary Supplement
Intervention Name(s)
spermidineLife
Intervention Description
dietary supplement that is made of natural wheat germ extract with high spermidine content
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
dietary supplement that is made of cellulose.
Primary Outcome Measure Information:
Title
Cardiorespiratory exercise capacity
Description
Change in cardiorespiratory exercise capacity (VO2peak) in ml/min/kg before and after of exercise training
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Diastolic function
Description
Change in diastolic function based on echocardiography (E/e')
Time Frame
16 weeks
Title
Microvascular function
Description
Reactive hyperemia index assessed using EndoPat
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Multiple-Choice Vocabulary Intelligence Test (MWT-B)
Description
Multiple-Choice Vocabulary Intelligence Test: Measure: total number of correctly checked lines. Final outcome: IQ (standard value and percentile rank)
Time Frame
16 weeks
Title
Mnemonic Similarity Task (MST)
Description
Mnemonic Similarity Task (MST). % of correctly answered tasks (0 - 100 %). final outcome: D - Prime
Time Frame
16 weeks
Title
Verbal Learning and Memory Test (VLMT)
Description
Verbal Learning and Memory Test (VLMT) % of correctly answered tasks (0 - 100 %). final outcome: D - Prime
Time Frame
16 weeks
Title
Digit Span test battery for attention testing
Description
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
Time Frame
16 weeks
Title
brain magnetic resonance imaging (MRI) - T1
Description
brain magnetic resonance imaging (MRI) T1 to assess cortical brain structure pre and post intervention
Time Frame
16 weeks
Title
brain magnetic resonance imaging (MRI) - FLAIR
Description
brain magnetic resonance imaging (MRI) - FLAIR to assess white matter hyperintensities pre and post intervention
Time Frame
16 weeks
Title
brain magnetic resonance imaging (MRI) - DTI
Description
brain magnetic resonance imaging (MRI) - DTI to assess fractional anisotropy and fiber tracking pre and post intervention
Time Frame
16 weeks
Title
brain magnetic resonance imaging (MRI) - resting state fMRI
Description
brain magnetic resonance imaging (MRI) resting state fMRI to assess brain network connectivity pre and post intervention
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcus Dörr, MD
Phone
+4938348680500
Email
marcus.doerr@med.uni-greifswald.de
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Bahls, PhD
Phone
+4938348680500
Email
martin.bahls@med.uni-greifswald.de
Facility Information:
Facility Name
Cardiovascular examination center of the University Medicine Greifswald
City
Greifswald
ZIP/Postal Code
17489
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Bahls, Ph.D.
Phone
+49 3834 8680500
Email
martin.bahls@uni-greifswald.de

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Our ethics approval does not allow to share IPD for this trial.

Learn more about this trial

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

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