Heart Failure Clinical Trial
Heart Failure Optimization Study
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.
Full Description
This study will be conducted at thirty to sixty sites, initially in US and Europe. It will be used to observe the rate of recovery of ventricular function (EF>35%) between 90 and 180 days in newly diagnosed HF patients 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 non-ischemic cardiomyopathy, and have already used a WCD for 90 ± 14 days. For the first 90 days of WCD use, patients will be enrolled in a pre-study registry. The FDA-approved WCD will be prescribed for up to 6 months of use after hospital discharge, with the option for longer use under physician discretion. Approximately 870 subjects will enroll into the pre-study registry and 750 subjects into the study.
Eligibility Criteria
Inclusion Criteria:
Part 1
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).
Part 2
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 already used a WCD for 90 ± 14 days.
Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not need to be low to be included in the study.
Exclusion Criteria:
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.
Patients who are indicated for cardiac resynchronization therapy or have a QRS duration of ≥135 ms.
Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).
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There are 63 Locations for this study
Birmingham Alabama, 35294, United States
West Hills California, 91307, United States
Fernandina Beach Florida, 32034, United States
Jacksonville Beach Florida, 32250, United States
Jacksonville Florida, 32207, United States
Ocala Florida, 34471, United States
Orlando Florida, 32825, United States
Saint Petersburg Florida, 33709, United States
Aurora Illinois, 60506, United States
Hazel Crest Illinois, 60429, United States
Peoria Illinois, 61602, United States
Munster Indiana, 46321, United States
South Bend Indiana, 26554, United States
London Kentucky, 40741, United States
Boston Massachusetts, 02114, United States
Saginaw Michigan, 48602, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64111, United States
Lake Saint Louis Missouri, 63367, United States
Saint Louis Missouri, 63136, United States
Hackensack New Jersey, 07601, United States
Pomona New Jersey, 08240, United States
Voorhees New Jersey, 08043, United States
Buffalo New York, 14215, United States
Liverpool New York, 13088, United States
Chapel Hill North Carolina, 27599, United States
Barberton Ohio, 44203, United States
Philadelphia Pennsylvania, 19102, United States
Philadelphia Pennsylvania, 19140, United States
Sayre Pennsylvania, 18840, United States
Lancaster South Carolina, 29720, United States
Sioux Falls South Dakota, 57104, United States
Memphis Tennessee, 38104, United States
Memphis Tennessee, 38116, United States
Oak Ridge Tennessee, 37830, United States
Dallas Texas, 75231, United States
New Braunfels Texas, 78130, United States
Waco Texas, 76712, United States
Huntington West Virginia, 25702, United States
Linz , 4020, Austria
Vienna , , Austria
Corbeil-Essonnes , 91106, France
Grenoble , 38043, France
Grenoble , 63003, France
Paris , 75015, France
Rennes , 35033, France
Toulouse , 31076, France
Dachau Bavaria, 85221, Germany
Regensburg Bayern, 93042, Germany
Villingen-Schwenningen Deutschland, 78052, Germany
Essen NRW, 45138, Germany
Augsburg , 86156, Germany
Bad Neustadt an der Saale , 97616, Germany
Barmbek , 22291, Germany
Berlin , , Germany
Cologne , 50733, Germany
Duesseldorf , 40225, Germany
Giessen , 35392, Germany
Goslar , 38642, Germany
Halle , 06120, Germany
Hamburg , 22043, Germany
Hamburg , , Germany
Hannöver , 30625, Germany
Leipzig , 04289, Germany
Ludenscheid , 58515, Germany
Lunen , 44534, Germany
Ulm , , Germany
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