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Heart Failure Optimization Study (HF-Opt)

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ClinicalTrials.gov Identifier: NCT03016754
Recruitment Status : Recruiting
First Posted : January 11, 2017
Last Update Posted : November 1, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Sudden Cardiac Death Sudden Cardiac Arrest Heart Failure Heart Failure Low Output 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
Estimated Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Heart Failure Optimization Study
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: Wearable Cardioverter Defibrillator
    LifeVest Wearable Cardioverter Defibrillator
    Other Name: LifeVest


Primary Outcome Measures :
  1. 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.

  2. Continue WCD use [ Time Frame: 180 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.

  3. Meet GDMT [ Time Frame: 180 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 :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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:
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016754


Contacts
Contact: Rachel Jackson 412-968-3333 ext 14118 rjackson@zoll.com
Contact: Mike Osz 412-721-6444 mosz@zoll.com

  Hide Study Locations
Locations
United States, California
Study Site Recruiting
West Hills, California, United States, 91307
Contact: Rafii         
United States, Florida
Baptist Heart Specialists Recruiting
Fernandina Beach, Florida, United States, 32034
Contact: Le-Bert         
Baptist Heart Specialists Recruiting
Jacksonville Beach, Florida, United States, 32250
Contact: Galani         
Baptist Heart Specialists Recruiting
Jacksonville, Florida, United States, 32207
Contact: Shroff         
Institute of Cardiovascular Research Recruiting
Ocala, Florida, United States, 34471
Contact: Gummadi         
Research Physicians Network Alliance Recruiting
Orlando, Florida, United States, 32825
Contact: Ambati         
Study Site Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: Sanchez         
United States, Illinois
Fox Valley Clinical Research Center Recruiting
Aurora, Illinois, United States, 60506
Contact: Muneer         
Chicago Medical Research, LLC Recruiting
Hazel Crest, Illinois, United States, 60429
Contact: Chandra         
Unity Point Health-Methodist Recruiting
Peoria, Illinois, United States, 61602
Contact: Adler         
United States, Indiana
Cardiovascular Research of Northwest Indiana, LLC Recruiting
Munster, Indiana, United States, 46321
Contact: Kesani         
Beacon Medical Group clinical Research Recruiting
South Bend, Indiana, United States, 26554
Contact: Kobayashi         
United States, Mississippi
Jackson Heart Clinic Recruiting
Jackson, Mississippi, United States, 39216
Contact: Colley         
United States, Missouri
Saint Luke's Hospital of Kansas City Recruiting
Kansas City, Missouri, United States, 64111
Contact: Kao         
St. Louis Heart and Vascular Recruiting
Saint Louis, Missouri, United States, 63136
Contact: Saheta         
United States, New Jersey
Lourdes Cardiology Services Recruiting
Voorhees, New Jersey, United States, 08043
Contact: Mohapatra         
United States, New York
Trinity Medical Center Recruiting
Buffalo, New York, United States, 14215
Contact: Deshmukh         
SJH Cardiology Recruiting
Liverpool, New York, United States, 13088
Contact: Kazzaz         
United States, Ohio
City Cardiology Associates Recruiting
Barberton, Ohio, United States, 44203
Contact: Haque         
United States, Pennsylvania
Drexel University Recruiting
Philadelphia, Pennsylvania, United States, 19102
Contact: Kutalek         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Brisco-Bacik         
Guthrie Medical Group, P.C. Recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Kaluski         
United States, South Carolina
Carolina Heart Specialists Recruiting
Lancaster, South Carolina, United States, 29720
Contact: Shah         
United States, Tennessee
Methodist University Hospital (MUH) and Methodist OliveBranch (MOB) Recruiting
Memphis, Tennessee, United States, 38104
Contact: Khouzam         
Methodist South (MS) University Hospital Recruiting
Memphis, Tennessee, United States, 38116
Contact: Dishmon         
Parkway Cardiology Recruiting
Oak Ridge, Tennessee, United States, 37830
Contact: Vohra         
United States, Texas
Texas Health Research & Education Institute Recruiting
Dallas, Texas, United States, 75231
Contact: Cheirif         
Mission Research Insitute Recruiting
New Braunfels, Texas, United States, 78130
Contact: Rubalcava         
United States, West Virginia
St. Mary's Medical Center Recruiting
Huntington, West Virginia, United States, 25702
Contact: Cheema         
Germany
Klinikum Augsburg Recruiting
Augsburg, Germany, 86156
Contact: von Scheidt         
Herz- und Gefäßklinik Bad Neustadt Recruiting
Bad Neustadt an der Saale, Germany, 97616
Contact: Deneke         
St. Vinzenz Hospital Recruiting
Cologne, Germany, 50733
Contact: Winter         
UKGM, Standort Giessen Recruiting
Giessen, Germany, 35392
Contact: Schmitt         
Asklepios Harzklinik Goslar Recruiting
Goslar, Germany, 38642
Contact: Wittlinger         
Asklepios Klinik Wandsbek Recruiting
Hamburg, Germany, 22043
Contact: Wietholt         
Medizinische Hochschule Hannover Recruiting
Hannöver, Germany, 30625
Contact: Veltmann         
Herzzentrum Leipzig GmbH Recruiting
Leipzig, Germany, 04289
Contact: Kuhl         
Katholisches Klinikum Lunen Recruiting
Lunen, Germany, 44534
Contact: Perings         
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: Mike Osz Director, Clinical Operations

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03016754     History of Changes
Other Study ID Numbers: 90D0109
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: November 1, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
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