Heart Failure Optimization Study (NCT03016754) | Clinical Trial Compass
CompletedNot Applicable
Heart Failure Optimization Study
United States, Austria, France602 participantsStarted 2017-03-01
Plain-language summary
This study is designed as a multi-center prospective observational study of newly diagnosed Heart Failure (HF) patients to test the hypothesis that additional Ejection Fraction (EF) recovery occurs between 90 and 180 days as Guideline Directed Medical Therapy (GDMT) is achieved. Although the study doesn't start until day 90, all eligible, consenting patients will be entered into a registry at the start of wearable cardioverter defibrillator (WCD) use. The pre-study registry will allow us to collect early (90 day) outcomes and data in those patients who are likely to be eligible for the study at day 90, or are eligible, but refuse the study at day 90.
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:
Phase 1 (Registry phase)
* Patients (≥18 years old) who were prescribed the WCD ≤ 10 days post-discharge after hospitalization for a primary reason of new onset HF (≤30 days since first HF hospitalization), with ischemic or nonischemic cardiomyopathy, and have used the WCD for no more than 30 days.
* Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times).
Phase 2 (Study phase)
* Patients who completed Phase 1 and used a WCD for 90 ± 14 days.
Exclusion Criteria (both phases):
* Patients under 18 years old.
* Patients who have an active unipolar pacemaker.
* Patients with a physical or mental condition that could impair their ability to properly interact with the device.
* Patients currently participating in another clinical study.
* Patients with any skin condition that would prevent wearing the device.
* Patients with an advanced directive prohibiting resuscitation.
Exclusion criteria (Phase 2)
* Patients who have a QRS duration of ≥135 ms and are planned for cardiac resynchronization therapy.
* Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).
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
Percentage of Patients With LVEF Recovery at Day 90 and 180
Timeframe: 180 days
2
Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)