Sudden Cardiac DeathHF-OptNCT03016754
Heart Failure Optimization Study
An observational study of Sudden Cardiac Death and Sudden Cardiac Arrest, run by Zoll Medical Corporation at 67 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Sudden Cardiac Arrest, Heart Failure
- What is being tested?
- Wearable Cardioverter Defibrillator
- Type of treatment
- Medical device
- How many people
- 602 participants
- Where
- 67 sitesin 4 countries
- Study dates
- 1 Mar 2017to 1 Jun 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
67 sites in 4 countries.
67 sites in 4 countries
United States39 sites
Fox Valley Clinical Research Center
Aurora, Illinois, 60506
City Cardiology Associates
Barberton, Ohio, 44203
UAB Division of Cardiovascular Disease
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Trinity Medical Center
Buffalo, New York, 14215
UNC Chapel Hill
Chapel Hill, North Carolina, 27599
Texas Health Research & Education Institute
Dallas, Texas, 75231
Baptist Heart Specialists
Fernandina Beach, Florida, 32034
Hackensack Meridian Health
Hackensack, New Jersey, 07601
Chicago Medical Research, LLC
Hazel Crest, Illinois, 60429
St. Mary's Medical Center
Huntington, West Virginia, 25702
Jackson Heart Clinic
Jackson, Mississippi, 39216
Baptist Heart Specialists
Jacksonville, Florida, 32207
Baptist Heart Specialists
Jacksonville Beach, Florida, 32250
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
SSM Health Heart & Vascular
Lake Saint Louis, Missouri, 63367
Carolina Heart Specialists
Lancaster, South Carolina, 29720
SJH Cardiology
Liverpool, New York, 13088
Saint Joseph London
London, Kentucky, 40741
Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)
Memphis, Tennessee, 38104
Methodist South (MS) University Hospital
Memphis, Tennessee, 38116
Cardiovascular Research of Northwest Indiana, LLC
Munster, Indiana, 46321
Mission Research Insitute
New Braunfels, Texas, 78130
Parkway Cardiology
Oak Ridge, Tennessee, 37830
Institute of Cardiovascular Research
Ocala, Florida, 34471
Research Physicians Network Alliance
Orlando, Florida, 32825
Unity Point Health-Methodist
Peoria, Illinois, 61602
Drexel University
Philadelphia, Pennsylvania, 19102
Temple University Hospital
Philadelphia, Pennsylvania, 19140
AtlantiCare Regional Medical Center
Pomona, New Jersey, 08240
Covenant Medical Center, Inc.
Saginaw, Michigan, 48602
Guthrie Medical Group, P.C.
Sayre, Pennsylvania, 18840
Sanford Health
Sioux Falls, South Dakota, 57104
Beacon Medical Group clinical Research
South Bend, Indiana, 26554
St. Louis Heart and Vascular
St Louis, Missouri, 63136
Study Site
St. Petersburg, Florida, 33709
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043
Providence Health Center
Waco, Texas, 76712
Study Site
West Hills, California, 91307
Germany20 sites
Klinikum Augsburg
Augsburg, 86156
Herz- und Gefäßklinik Bad Neustadt
Bad Neustadt an der Saale, 97616
Asklepios Klinik Barmbek
Barmbek, 22291
Charité Universitätsmedizin Berlin
Berlin
St. Vinzenz Hospital
Cologne, 50733
Amper Kliniken AG, Heliios Amper-Klinikum Dachau
Dachau, Bavaria, 85221
Universitaetsklinikum Duesseldorf
Düsseldorf, 40225
Elisabeth-Krankenhaus
Essen, North Rhine-Westphalia, 45138
UKGM, Standort Giessen
Giessen, 35392
Asklepios Harzklinik Goslar
Goslar, 38642
Universitatsklinikum Halle
Halle, 06120
Asklepios Klinik Wandsbek
Hamburg, 22043
Kardiologie, Asklepios Klinik St. Georg
Hamburg
Medizinische Hochschule Hannover
Hannover, 30625
Herzzentrum Leipzig GmbH
Leipzig, 04289
Klinikum Ludenscheid
Lüdenscheid, 58515
Katholisches Klinikum Lunen
Lünen, 44534
Klinik u. Polikllinik Fur Innere Med. II Kardiologie
Regensburg, Bavaria, 93042
Universitätsklinikum Ulm
Ulm
Schwarzwald-Baar Klinik
Villingen-Schwenningen, Deutschland, 78052
France6 sites
Centre Hospitalier Sud Francilien
Corbeil-Essonnes, 91106
CHU de Grenoble site Nord- Hopital Albert Michallon
Grenoble, 38043
CHU de Clermont-Ferrand- Hopital Albert Michallon
Grenoble, 63003
Hopital Europeen Georges Pompidou
Paris, 75015
CHU Pontchaillou
Rennes, 35033
Clinique Pasteur
Toulouse, 31076
Austria2 sites
Ordensklinikum Linz GmbH/Elisabethinen
Linz, 4020
Medizinische Universitätsklinik Wien
Vienna
About this study
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.
Read the 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.
- Being tested
- Wearable Cardioverter Defibrillator
- 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)
- Medical subject headings
- Death, Sudden, Cardiac, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable Cardioverter DefibrillatorDevice
Also called LifeVest
LifeVest is the brand of Wearable Cardioverter Defibrillator used in this study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Wearable Cardioverter Defibrillator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 180 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 360 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start1 Mar 2017
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Osz, Study director, Director, Clinical Operations
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03016754
- Sponsor's protocol ID
- 90D0109
- Acronym
- HF-Opt
- Status last verified
- Mar 2025
- First submitted
- 4 Jan 2017
- Last updated
- 24 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Failure Optimization Study
- ClinicalTrials.gov ID
- NCT03016754
- Acronym / sponsor ID
- HF-Opt / 90D0109
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Posted 24 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Device: Wearable Cardioverter DefibrillatorPatients 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. |
| Non-improvement | – | Device: Wearable Cardioverter DefibrillatorPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable Cardioverter DefibrillatorAlso: LifeVestLifeVest is the brand of Wearable Cardioverter Defibrillator used in this study. | Device | Improvement, Non-improvement |
Primary outcome
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.
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.
7 secondary outcomes
All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use
Time frame: 360 days
All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use
Time frame: 360 days
Percentage of All Patients Having Other Arrhythmias
Time frame: 180 days
Efficacy in Treating Ventricular Arrhythmias
Time frame: 180 days
Mortality Analysis
Time frame: 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_length of Use
Time frame: 360 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mike Osz study director
Director, Clinical Operations
67 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death and Sudden Cardiac Arrest, run by Zoll Medical Corporation at 67 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, Germany, France, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With LVEF Recovery at Day 90 and 180 (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.