Heart Failure Optimization Study (HF-Opt)

March 20, 2025 updated by: Zoll Medical Corporation
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
602

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Patients With LVEF Recovery at Day 90 and 180
Time Frame: 180 days
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)
Time Frame: 180 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use
Time Frame: 360 days
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
Time Frame: 360 days
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
Time Frame: 180 days
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
Time Frame: 180 days
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
Time Frame: 0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months)
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
Time Frame: 360 days
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
Time Frame: 360 days
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications From Extended Use
Time Frame: 360 days
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zoll Medical Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mike Osz, Director, Clinical Operations

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 11, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 90D0109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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