Heart Failure Optimization Study (HF-Opt)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Sudden Cardiac Death; Sudden Cardiac Arrest; Heart Failure Low Output
• Intervention / Treatment: Device: Wearable Cardioverter Defibrillator

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.

• Study Type: Observational
• Enrollment (Actual): 602

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH/Elisabethinen
  • Vienna, Austria
    • Medizinische Universitätsklinik Wien
• France
  • Corbeil-Essonnes, France, 91106
    • Centre Hospitalier Sud Francilien
  • Grenoble, France, 38043
    • CHU de Grenoble site Nord- Hopital Albert Michallon
  • Grenoble, France, 63003
    • CHU de Clermont-Ferrand- Hopital Albert Michallon
  • Paris, France, 75015
    • Hôpital Européen Georges Pompidou
  • Rennes, France, 35033
    • CHU Pontchaillou
  • Toulouse, France, 31076
    • Clinique Pasteur
• Germany
  • Augsburg, Germany, 86156
    • Klinikum Augsburg
  • Bad Neustadt an der Saale, Germany, 97616
    • Herz- und Gefäßklinik Bad Neustadt
  • Barmbek, Germany, 22291
    • Asklepios Klinik Barmbek
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin
  • Cologne, Germany, 50733
    • St. Vinzenz Hospital
  • Duesseldorf, Germany, 40225
    • Universitaetsklinikum Duesseldorf
  • Giessen, Germany, 35392
    • UKGM, Standort Giessen
  • Goslar, Germany, 38642
    • Asklepios Harzklinik Goslar
  • Halle, Germany, 06120
    • Universitatsklinikum Halle
  • Hamburg, Germany, 22043
    • Asklepios Klinik Wandsbek
  • Hamburg, Germany
    • Kardiologie, Asklepios Klinik St. Georg
  • Hannöver, Germany, 30625
    • Medizinische Hochschule Hannover
  • Leipzig, Germany, 04289
    • Herzzentrum Leipzig GmbH
  • Ludenscheid, Germany, 58515
    • Klinikum Lüdenscheid
  • Lunen, Germany, 44534
    • Katholisches Klinikum Lunen
  • Ulm, Germany
    • Universitatsklinikum Ulm
  • Bavaria
    • Dachau, Bavaria, Germany, 85221
      • Amper Kliniken AG, Heliios Amper-Klinikum Dachau
  • Bayern
    • Regensburg, Bayern, Germany, 93042
      • Klinik u. Polikllinik Fur Innere Med. II Kardiologie
  • Deutschland
    • Villingen-Schwenningen, Deutschland, Germany, 78052
      • Schwarzwald-Baar Klinik
  • NRW
    • Essen, NRW, Germany, 45138
      • Elisabeth-Krankenhaus
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Division of Cardiovascular Disease
  • California
    • West Hills, California, United States, 91307
      • Study Site
  • Florida
    • Fernandina Beach, Florida, United States, 32034
      • Baptist Heart Specialists
    • Jacksonville, Florida, United States, 32207
      • Baptist Heart Specialists
    • Jacksonville Beach, Florida, United States, 32250
      • Baptist Heart Specialists
    • Ocala, Florida, United States, 34471
      • Institute of Cardiovascular Research
    • Orlando, Florida, United States, 32825
      • Research Physicians Network Alliance
    • Saint Petersburg, Florida, United States, 33709
      • Study Site
  • Illinois
    • Aurora, Illinois, United States, 60506
      • Fox Valley Clinical Research Center
    • Hazel Crest, Illinois, United States, 60429
      • Chicago Medical Research, LLC
    • Peoria, Illinois, United States, 61602
      • Unity Point Health-Methodist
  • Indiana
    • Munster, Indiana, United States, 46321
      • Cardiovascular Research of Northwest Indiana, LLC
    • South Bend, Indiana, United States, 26554
      • Beacon Medical Group Clinical Research
  • Kentucky
    • London, Kentucky, United States, 40741
      • Saint Joseph London
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Saginaw, Michigan, United States, 48602
      • Covenant Medical Center, Inc.
  • Mississippi
    • Jackson, Mississippi, United States, 39216
      • Jackson Heart Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Saint Luke's Hospital of Kansas City
    • Lake Saint Louis, Missouri, United States, 63367
      • SSM Health Heart & Vascular
    • Saint Louis, Missouri, United States, 63136
      • St. Louis Heart and Vascular
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack Meridian Health
    • Pomona, New Jersey, United States, 08240
      • AtlantiCare Regional Medical Center
    • Voorhees, New Jersey, United States, 08043
      • Lourdes Cardiology Services
  • New York
    • Buffalo, New York, United States, 14215
      • Trinity Medical Center
    • Liverpool, New York, United States, 13088
      • SJH Cardiology
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Chapel Hill
  • Ohio
    • Barberton, Ohio, United States, 44203
      • City Cardiology Associates
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University Hospital
    • Philadelphia, Pennsylvania, United States, 19102
      • Drexel University
    • Sayre, Pennsylvania, United States, 18840
      • Guthrie Medical Group, P.C.
  • South Carolina
    • Lancaster, South Carolina, United States, 29720
      • Carolina Heart Specialists
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Health
  • Tennessee
    • Memphis, Tennessee, United States, 38104
      • Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)
    • Memphis, Tennessee, United States, 38116
      • Methodist South (MS) University Hospital
    • Oak Ridge, Tennessee, United States, 37830
      • Parkway Cardiology
  • Texas
    • Dallas, Texas, United States, 75231
      • Texas Health Research & Education Institute
    • New Braunfels, Texas, United States, 78130
      • Mission Research Insitute
    • Waco, Texas, United States, 76712
      • Providence Health Center
  • West Virginia
    • Huntington, West Virginia, United States, 25702
      • St. Mary's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.; Other Names: LifeVest
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; LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.; Other Names: LifeVest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use	Observe the percentage of patients having sustained VT/VF arrhythmias during WCD use. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.	360 days
All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use	Observe the occurrence of all sustained VT/VF arrhythmias during WCD use by event. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.	360 days
Percentage of All Patients Having Other Arrhythmias	Observe the percentage of patients having other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.	180 days
Efficacy in Treating Ventricular Arrhythmias	Observe the effectiveness of the wearable cardioverter defibrillator worn by this population in treating ventricular arrhythmias. As this was a secondary outcome to describe events during all WCD use, all eligible registry subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.	180 days
Mortality Analysis	Evaluate the effect of wearable defibrillators on 180, 270, and 360-day mortality following discharge in HF patients. Cumulative assessment of survival will be made at these time points for those entered into the study (e.g. up to 180, 270, 360 days, or >360 days (up to 14 months)). A mortality review will be conducted by independent adjudicators to group all deaths as cardiac or non-cardiac, and sudden or non-sudden. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes. Data collected on deaths after the prespecified final timepoint (n=3) will be labeled >360 days (up to 14 months). 1 subject completed the study immediately prior to the reported death, hence the different number from the participant flow.	0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months)
Healthcare utilization_type	Healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study. All eligible study subjects were used for this analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.	360 days
Healthcare utilization_length of Use	Length of stay for any hospitalization, observation, skilled nursing facility stays. All eligible study subjects reporting one of these stays were used for this analysis, and grouped by type of stay. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.	360 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications From Extended Use	The safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study phase timeframe. All eligible study subjects were used for this safety analysis. Participants were not split into groups for secondary analyses, only for reporting results of left ventricular ejection fraction (LVEF) recovery in the primary outcomes.	360 days

Collaborators and Investigators

• Sponsor: Zoll Medical Corporation
• Investigators: Study Director: Mike Osz, Director, Clinical Operations

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimated): January 11, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 20, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: heart failure (HF); sudden cardiac death (SCD); sudden cardiac arrest (SCA); heart failure with reduced ejection fraction (HFrEF); guideline directed medical therapy (GDMT); guideline recommended medical therapy (GRMT); wearable cardioverter defibrillator (WCD)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Death, Sudden; Heart Failure; Heart Arrest; Death, Sudden, Cardiac; Death
• Other Study ID Numbers: 90D0109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO