UnknownNot Applicable

Conditioning Based Intervention Strategies

Denmark84 participantsStarted 2016-09-01

Plain-language summary

The overall objective of this study is to uncover and utilize the mechanisms behind the activation of endogenous organ protection by remote ischemic conditioning (RIC), high intensity traditional resistance training (TRT) and low intensity blood flow restricted resistance exercise (BFRE) with the perspective of defining their applicability for immediate organ protection in ischemia-reperfusion injury (acute conditioning) and subsequent tissue repair (chronic conditioning) during a prolonged recovery period. This objective will be achieved by studying which and how molecular pathways underlying these protective mechanisms are shared and can be transferred to treat medical conditions. A specific focus is the roles of EVs and miRNAs. Another objective is to explore how exercise training with and without ischemia can counteract muscle wasting.

Who can participate

Age range

18 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Able to understand the written and spoken information and to give informed consent for inclusion. * Age between 18 and 80 years * Able to sit in a knee extension machine * Able to deliver muscle biopsies * Able to train 3 times per week during a 6-week period Inclusion Criteria - heart failure patients * Chronic congestive ischemic heart failure * LV ejection fraction ≤45% * NYHA function class II-IV Inclusion Criteria - healthy subjects • See general criteria for inclusion Exclusion Criteria - healthy subjects * Myocardial infarction * Angina pectoris Exclusion Criteria: * Pregnancy * Diabetes mellitus * Peripheral neuropathy * Dialysis treatment * Severe peripheral arterial disease * Concomitant acute life threatening medical condition * Medications known to modify the effect of ischemic conditioning such as cyclosporin and glibenclamide. * Recent cardiovascular hospitalization (within last 30 days) * Intracranial aneurisms, arteriovenous malformation, cerebral neoplasm or abscess. * Myocardial infarction * Angina pectoris * Severe arterial hypertension (≥ 180/≥ 110 mmHg) or moderate arterial hypertension (160-179/100-109) despite medical treatment. * Moderate to severe cardiac valve disease * Beta blocker medication * Moderate or severe chronic obstructive pulmonary disease * Decreased kidney function - eGFR \< 60 ml/min. Criteria for stopping the intervention or investigations * Severe discomfort and/or by request of the participant. * Saf…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes in miRNA and EV content in blood samples

Timeframe: 6 Weeks

Trial details

NCT IDNCT03380663

SponsorUniversity of Aarhus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-10-01

Contact for this trial

Frank de Paoli, MD, PhD

+45 61460880 fdp@biomed.au.dk

View on ClinicalTrials.gov More Ischemic Preconditioning trials