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Heart Failure Optimization Study (HF-Opt)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2017 by Zoll Medical Corporation
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT03016754
First received: January 4, 2017
Last updated: January 6, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention
Sudden Cardiac Death
Sudden Cardiac Arrest
Heart Failure
Heart Failure Low Output
Device: Wearable Cardioverter Defibrillator

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Failure Optimization Study

Resource links provided by NLM:


Further study details as provided by Zoll Medical Corporation:

Primary Outcome Measures:
  • Do not require ICD implant [ Time Frame: 180 days ]
    Patient improved (EF >35%), SCD risk deemed to be negligible. These patients will end WCD use and not receive an ICD.

  • Continue WCD use [ Time Frame: 270 days ]
    Patient improved EF from start of WCD use (a positive change of at least 5 percentage points in EF), or has a borderline EF of 30-35%, but still has continued SCD risk (EF ≤ 35%). These patients are expected to continue to use the WCD for an additional 3 months.

  • Meet GDMT [ Time Frame: 270 days ]
    Patient not improved from start of WCD use (no change or worsening of EF), EF<30% and has continued high SCD risk. These patients will either continue the WCD for an additional 90 days if not on GDMT, or receive an ICD if already on GDMT.


Secondary Outcome Measures:
  • Incidence of other arrhythmias [ Time Frame: 180 days ]
    Observe the incidence of other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device.

  • Determine the number of ICD treatment shocks [ Time Frame: 180 days ]
    Collect ICD treatment data for those who receive an ICD, and evaluate for appropriateness as assessed by ECG recordings.

  • Efficacy in ventricular arrhythmias [ Time Frame: 180 days ]
    Observe the effectiveness of the wearable defibrillator worn by this population in treating ventricular arrhythmias. Clinical outcomes data from any defibrillation or cardiac event will be collected, including device data on appropriate arrhythmia detection and shock delivery.

  • Mortality following hospital discharge [ Time Frame: 360 days ]
    Evaluate the effect of wearable defibrillators on 90,180, 270, and 360-day mortality following discharge in HF patients. Assessment of survival will be made at these time points for those entered into the study. A mortality review will be conducted to group all deaths as cardiac or non-cardiac, and sudden or non-sudden.

  • Cost of healthcare utilization [ Time Frame: 360 days ]
    Assess cost of healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study.


Other Outcome Measures:
  • 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 timeframe.


Estimated Enrollment: 750
Study Start Date: January 2017
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Wearable Cardioverter Defibrillator
    Other Name: LifeVest
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In-Hospital
Criteria

Inclusion Criteria:

Part 1

  • 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).

Part 2

  • 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 already used a WCD for 90 ± 14 days.
  • Patients who had an EF ≤ 35% during index hospitalization (must be last measurement if performed multiple times). Of note, EF at 90 ± 14 days post-hospitalization does not need to be low to be included in the study.

Exclusion Criteria:

  • 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 are indicated for cardiac resynchronization therapy or have a QRS duration of ≥135 ms.
  • Patients with recent myocardial infarction or coronary revascularization (since start of WCD wear; i.e. 0-90 days of WCD wear).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03016754

Contacts
Contact: Nicole Rose 412-968-3333 ext 14417 nrose@zoll.com
Contact: Mike Osz 412-721-6444 mosz@zoll.com

Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: MIke Osz Director, Clinical Operations
  More Information

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03016754     History of Changes
Other Study ID Numbers: 90D0109
Study First Received: January 4, 2017
Last Updated: January 6, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Zoll Medical Corporation:
sudden cardiac death
SCD
sudden cardiac arrest
SCA
heart failure
HF

Additional relevant MeSH terms:
Heart Failure
Heart Arrest
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden

ClinicalTrials.gov processed this record on April 21, 2017