Heart Failure Optimization Study

NCT03016754 | Completed Results

• 1 other identifier: 90D0109
• Study Type: observational
• Target: 602
• Locations: 4 countries
• Sites: 67

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.

Conditions

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

Keywords

sudden cardiac death (SCD); sudden cardiac arrest (SCA); heart failure (HF); heart failure with reduced ejection fraction (HFrEF); guideline directed medical therapy (GDMT); guideline recommended medical therapy (GRMT); wearable cardioverter defibrillator (WCD)

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients With LVEF Recovery at Day 90 and 180

  The percentage of patients reaching the goal of LVEF\>35% will be compared at 90 days and 180 days. Echocardiographic assessment of LVEF was used.

  180 days

• Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)

  Descriptive statistics will be used to assess the percentage of study subjects reaching target doses of GDMT at 90 and 180 days. All eligible study subjects with LVEF data at all three timepoints were used for this analysis.

  180 days

Secondary Outcomes (7)

• All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use

  360 days

• All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use

  360 days

• Percentage of All Patients Having Other Arrhythmias

  180 days

• Efficacy in Treating Ventricular Arrhythmias

  180 days

• Mortality Analysis

  0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months)

Other Outcomes (1)

• Complications From Extended Use

  360 days

Study Arms (3)

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.

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.

Device: Wearable Cardioverter Defibrillator

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.

Device: Wearable Cardioverter Defibrillator

Interventions

Wearable Cardioverter Defibrillator DEVICE

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

Also known as: LifeVest

Improvement; Non-improvement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients (≥18 years old) who used a WCD for 90 days after hospitalization for a primary reason of new onset HF with ischemic or nonischemic cardiomyopathy.

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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (67)

UAB Division of Cardiovascular Disease

Birmingham, Alabama, 35294, United States

Location

Study Site

West Hills, California, 91307, United States

Location

Baptist Heart Specialists

Fernandina Beach, Florida, 32034, United States

Location

Baptist Heart Specialists

Jacksonville, Florida, 32207, United States

Location

Baptist Heart Specialists

Jacksonville Beach, Florida, 32250, United States

Location

Institute of Cardiovascular Research

Ocala, Florida, 34471, United States

Location

Research Physicians Network Alliance

Orlando, Florida, 32825, United States

Location

Study Site

St. Petersburg, Florida, 33709, United States

Location

Fox Valley Clinical Research Center

Aurora, Illinois, 60506, United States

Location

Chicago Medical Research, LLC

Hazel Crest, Illinois, 60429, United States

Location

Unity Point Health-Methodist

Peoria, Illinois, 61602, United States

Location

Cardiovascular Research of Northwest Indiana, LLC

Munster, Indiana, 46321, United States

Location

Beacon Medical Group clinical Research

South Bend, Indiana, 26554, United States

Location

Saint Joseph London

London, Kentucky, 40741, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Covenant Medical Center, Inc.

Saginaw, Michigan, 48602, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111, United States

Location

SSM Health Heart & Vascular

Lake Saint Louis, Missouri, 63367, United States

Location

St. Louis Heart and Vascular

St Louis, Missouri, 63136, United States

Location

Hackensack Meridian Health

Hackensack, New Jersey, 07601, United States

Location

AtlantiCare Regional Medical Center

Pomona, New Jersey, 08240, United States

Location

Lourdes Cardiology Services

Voorhees Township, New Jersey, 08043, United States

Location

Trinity Medical Center

Buffalo, New York, 14215, United States

Location

SJH Cardiology

Liverpool, New York, 13088, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

City Cardiology Associates

Barberton, Ohio, 44203, United States

Location

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Guthrie Medical Group, P.C.

Sayre, Pennsylvania, 18840, United States

Location

Carolina Heart Specialists

Lancaster, South Carolina, 29720, United States

Location

Sanford Health

Sioux Falls, South Dakota, 57104, United States

Location

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

Memphis, Tennessee, 38104, United States

Location

Methodist South (MS) University Hospital

Memphis, Tennessee, 38116, United States

Location

Parkway Cardiology

Oak Ridge, Tennessee, 37830, United States

Location

Texas Health Research & Education Institute

Dallas, Texas, 75231, United States

Location

Mission Research Insitute

New Braunfels, Texas, 78130, United States

Location

Providence Health Center

Waco, Texas, 76712, United States

Location

St. Mary's Medical Center

Huntington, West Virginia, 25702, United States

Location

Ordensklinikum Linz GmbH/Elisabethinen

Linz, 4020, Austria

Location

Medizinische Universitätsklinik Wien

Vienna, Austria

Location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, 91106, France

Location

CHU de Grenoble site Nord- Hopital Albert Michallon

Grenoble, 38043, France

Location

CHU de Clermont-Ferrand- Hopital Albert Michallon

Grenoble, 63003, France

Location

Hopital Europeen Georges Pompidou

Paris, 75015, France

Location

CHU Pontchaillou

Rennes, 35033, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Amper Kliniken AG, Heliios Amper-Klinikum Dachau

Dachau, Bavaria, 85221, Germany

Location

Klinik u. Polikllinik Fur Innere Med. II Kardiologie

Regensburg, Bavaria, 93042, Germany

Location

Schwarzwald-Baar Klinik

Villingen-Schwenningen, Deutschland, 78052, Germany

Location

Elisabeth-Krankenhaus

Essen, North Rhine-Westphalia, 45138, Germany

Location

Klinikum Augsburg

Augsburg, 86156, Germany

Location

Herz- und Gefäßklinik Bad Neustadt

Bad Neustadt an der Saale, 97616, Germany

Location

Asklepios Klinik Barmbek

Barmbek, 22291, Germany

Location

Charité Universitätsmedizin Berlin

Berlin, Germany

Location

St. Vinzenz Hospital

Cologne, 50733, Germany

Location

Universitaetsklinikum Duesseldorf

Düsseldorf, 40225, Germany

Location

UKGM, Standort Giessen

Giessen, 35392, Germany

Location

Asklepios Harzklinik Goslar

Goslar, 38642, Germany

Location

Universitatsklinikum Halle

Halle, 06120, Germany

Location

Asklepios Klinik Wandsbek

Hamburg, 22043, Germany

Location

Kardiologie, Asklepios Klinik St. Georg

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hannover, 30625, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, 04289, Germany

Location

Klinikum Ludenscheid

Lüdenscheid, 58515, Germany

Location

Katholisches Klinikum Lunen

Lünen, 44534, Germany

Location

Universitätsklinikum Ulm

Ulm, Germany

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac; Heart Failure

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nicole Bianco
• Organization: ZOLL

nbianco@zoll.com

4129683333

Study Officials

• Mike Osz

  Director, Clinical Operations

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 11, 2017
• Study Start: March 1, 2017
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (20); FR (6); AU (2); US (39)