Heart Failure Optimization Study

Completed

Conditions: Heart Failure
Sudden Cardiac Death
Sudden Cardiac Arrest
Heart Failure Low Output

Registration Number: NCT03016754

Lead Sponsor: Zoll Medical Corporation

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 602

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).

Exclusion Criteria

Not provided

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Patients With LVEF Recovery at Day 90 and 180	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)	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.

Secondary Outcome Measures

Name	Time	Method
All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use	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.
All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use	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.
Percentage of All Patients Having Other Arrhythmias	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.
Efficacy in Treating Ventricular Arrhythmias	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.
Mortality Analysis	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.
Healthcare utilization_type	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.
Healthcare utilization_length of Use	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.

Trial Locations

Locations (64): UAB Division of Cardiovascular Disease
🇺🇸
Birmingham, Alabama, United States
Study Site
🇺🇸
Saint Petersburg, Florida, United States
Baptist Heart Specialists
🇺🇸
Jacksonville, Florida, United States
Institute of Cardiovascular Research
🇺🇸
Ocala, Florida, United States
Research Physicians Network Alliance
🇺🇸
Orlando, 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
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UAB Division of Cardiovascular Disease
🇺🇸Birmingham, Alabama, United States