Heart Failure Optimization Study

Completed

Conditions studied: Sudden Cardiac Death, Sudden Cardiac Arrest, Heart Failure, Heart Failure Low Output

In brief

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.

Key facts

Study ID

NCT03016754

Run by

Zoll Medical Corporation

People needed

602

Starts

2017-03-01

Expected to finish

2022-06-01

Last updated by the study team

2025-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

Where it is running

• Study Site — West Hills, California, United States
• Baptist Heart Specialists — Fernandina Beach, Florida, United States
• Baptist Heart Specialists — Jacksonville, Florida, United States
• Baptist Heart Specialists — Jacksonville Beach, Florida, United States
• Institute of Cardiovascular Research — Ocala, Florida, United States
• Research Physicians Network Alliance — Orlando, Florida, United States
• Study Site — St. Petersburg, Florida, United States
• Fox Valley Clinical Research Center — Aurora, Illinois, United States
• Chicago Medical Research, LLC — Hazel Crest, Illinois, United States
• Unity Point Health-Methodist — Peoria, Illinois, United States
• Cardiovascular Research of Northwest Indiana, LLC — Munster, Indiana, United States
• Beacon Medical Group clinical Research — South Bend, Indiana, United States
• Saint Joseph London — London, Kentucky, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Covenant Medical Center, Inc. — Saginaw, Michigan, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• SSM Health Heart & Vascular — Lake Saint Louis, Missouri, United States
• St. Louis Heart and Vascular — St Louis, Missouri, United States
• Hackensack Meridian Health — Hackensack, New Jersey, United States
• AtlantiCare Regional Medical Center — Pomona, New Jersey, United States
• Lourdes Cardiology Services — Voorhees Township, New Jersey, United States
• Trinity Medical Center — Buffalo, New York, United States
• SJH Cardiology — Liverpool, New York, United States
• UAB Division of Cardiovascular Disease — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.