Care-HF CArdiac Resynchronization in Heart Failure
813 participantsStarted 2001-01
Plain-language summary
The CARE-HF trial evaluates the effects of Cardiac Resynchronization (CR) therapy on the mortality and morbidity of patients with heart failure due to left ventricular systolic dysfunction already receiving diuretics and optimal medical therapy.
Who can participate
Age range
18 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:
* Heart failure for at least 6 weeks requiring loop diuretics
* Currently in NYHA class III/IV
* A high standard of pharmacological therapy
* LV systolic dysfunction and dilation (EF \<=35%; EDD \>30mm/height in metres)
* QRS \>=120 ms Dyssynchrony confirmed by echo if QRS 120-149 ms (Aortic pre-ejection delay \>140ms, Interventricular mechanical delay \>40 ms, Delayed activation of postero-lateral LV wall)
Exclusion Criteria:
* Age \< 18 years old or age \< legal age defined in the country in case different
* Chronic atrial fibrillation within 6 weeks prior to randomization;
* Impairment of left ventricular function not related to left ventricular systolic function
* Potentially reversible forms of cardiomyopathy:
* Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction,unstable severe angina or stroke within 6 weeks before randomization
* A conventional indication for bradyarrhythmia pacing exists;
* A conventional indication for an ICD exists
* A pacemaker or ICD has already been implanted;
* In-Patients requiring continuous intravenous therapy for Heart Failure;
* Life expectancy \< 1 year for disease unrelated to Heart Failure;
* Pregnancy or childbearing potential and not on reliable contraceptive;
* Mechanical tricuspid valve;
* Anticipated compliance problem or participation in another trial;
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
1
All cause mortality or unplanned cardiovascular hospitalization.