Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure (NCT02051712) | Clinical Trial Compass
UnknownPhase 3
Cardiovascular Effects of Preferred Home-based Exercise Training in Systolic Heart Failure
Germany120 participantsStarted 2014-02
Plain-language summary
The aim of the study is I. To assess whether an individualized exercise training program is superior as compared to usual care with respect to exercise tolerance, II. to assess whether intervention tools that aim to increase exercise adherence are superior to an individualized exercise training alone with respect to exercise tolerance and long-term effects, and III. to identify biomarkers that that may be implemented into novel intervention tools aiming to increase exercise adherence in patients with chronic heart failure.
Who can participate
Age range
30 Years – 75 Years
Sex
ALL
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:
* women and men
* age 30-75 years
* chronic heart failure (NYHA II/III), left ventricular ejection fraction ≤40% be echo
* disease duration ≥ 6 month
* medical therapy accruing to guidelines (drug, devices, including CRT)
* written informed consent
Exclusion Criteria:
* acute myocarditis
* instable angina
* heart surgery (e.g. ICD implantation, bypass) with last 6 weeks; CRT implantation within the last 6 months before study start
* severe cardiovascular events (myocardial infarction, cardiac decompensation, ICD shock, PCI due to instable angina) \< 6 weeks before study start
* preplanned hospital admission or intervention (e.g. planned revascularization, ICD implantation)
* uncorrected valve regurgitation or stenosis (\> second degree)
* safety concerns regarding or other reasons against exercise training
* severe depression
* regular exercise training within the last 6 weeks
* life expectancy \< 1 year
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.