Heart Failure Optimization Study

NCT ID: NCT03016754

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 602 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2022-06-01

Brief 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.

Detailed 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.

Conditions

Sudden Cardiac Death; Sudden Cardiac Arrest; Heart Failure; Heart Failure Low Output

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Early Recovery

Patients improved to LVEF \>35% within the first 90 days following GDMT. These patients are expected to end WCD use and not receive an implantable cardioverter defibrillator (ICD) according to current guidelines.

No interventions assigned to this group

Improvement

Patients improved LVEF from start of WCD use (a positive change of at least 5% in LVEF) or have borderline LVEF of 30-35% at day 90. These patients were expected, but not required to continue to use the WCD for an additional 90 days.

Wearable Cardioverter Defibrillator

Intervention Type: DEVICE

LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.

Non-improvement

Patients show no change, worsening of LVEF or LVEF \<30%. Those on GDMT are expected to be evaluated for an ICD. Those not yet on GDMT were expected, but not required, to continue the WCD for an additional 90 days.

Wearable Cardioverter Defibrillator

Intervention Type: DEVICE

LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.

Interventions

Wearable Cardioverter Defibrillator

LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.

Intervention Type: DEVICE

Other Intervention Names

LifeVest

Eligibility Criteria

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

• 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 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zoll Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mike Osz

Role: STUDY_DIRECTOR

Director, Clinical Operations

Locations

UAB Division of Cardiovascular Disease

Birmingham, Alabama, United States

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

UNC Chapel Hill

Chapel Hill, North Carolina, United States

City Cardiology Associates

Barberton, Ohio, United States

Drexel University

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Guthrie Medical Group, P.C.

Sayre, Pennsylvania, United States

Carolina Heart Specialists

Lancaster, South Carolina, United States

Sanford Health

Sioux Falls, South Dakota, United States

Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)

Memphis, Tennessee, United States

Methodist South (MS) University Hospital

Memphis, Tennessee, United States

Parkway Cardiology

Oak Ridge, Tennessee, United States

Texas Health Research & Education Institute

Dallas, Texas, United States

Mission Research Insitute

New Braunfels, Texas, United States

Providence Health Center

Waco, Texas, United States

St. Mary's Medical Center

Huntington, West Virginia, United States

Ordensklinikum Linz GmbH/Elisabethinen

Linz, , Austria

Medizinische Universitätsklinik Wien

Vienna, , Austria

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, , France

CHU de Grenoble site Nord- Hopital Albert Michallon

Grenoble, , France

CHU de Clermont-Ferrand- Hopital Albert Michallon

Grenoble, , France

Hopital Europeen Georges Pompidou

Paris, , France

CHU Pontchaillou

Rennes, , France

Clinique Pasteur

Toulouse, , France

Amper Kliniken AG, Heliios Amper-Klinikum Dachau

Dachau, Bavaria, Germany

Klinik u. Polikllinik Fur Innere Med. II Kardiologie

Regensburg, Bavaria, Germany

Schwarzwald-Baar Klinik

Villingen-Schwenningen, Deutschland, Germany

Elisabeth-Krankenhaus

Essen, North Rhine-Westphalia, Germany

Klinikum Augsburg

Augsburg, , Germany

Herz- und Gefäßklinik Bad Neustadt

Bad Neustadt an der Saale, , Germany

Asklepios Klinik Barmbek

Barmbek, , Germany

Charité Universitätsmedizin Berlin

Berlin, , Germany

St. Vinzenz Hospital

Cologne, , Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, , Germany

UKGM, Standort Giessen

Giessen, , Germany

Asklepios Harzklinik Goslar

Goslar, , Germany

Universitatsklinikum Halle

Halle, , Germany

Asklepios Klinik Wandsbek

Hamburg, , Germany

Kardiologie, Asklepios Klinik St. Georg

Hamburg, , Germany

Medizinische Hochschule Hannover

Hannover, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Klinikum Ludenscheid

Lüdenscheid, , Germany

Katholisches Klinikum Lunen

Lünen, , Germany

Universitätsklinikum Ulm

Ulm, , Germany

Countries

United States; Austria; France; Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

90D0109

Identifier Type: -

Identifier Source: org_study_id