HF-Opt: Heart Failure Optimization Study

Sponsor
Zoll Medical Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03016754
Collaborator
(none)
622
67
63
9.3
0.1

Study Details

Study Description

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 Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
622 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Heart Failure Optimization Study
Actual Study Start Date :
Mar 1, 2017
Actual Primary Completion Date :
Jun 1, 2022
Actual Study Completion Date :
Jun 1, 2022

Outcome Measures

Primary Outcome Measures

  1. Do not require ICD implant [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 UAB Division of Cardiovascular Disease Birmingham Alabama United States 35294
2 Study Site West Hills California United States 91307
3 Baptist Heart Specialists Fernandina Beach Florida United States 32034
4 Baptist Heart Specialists Jacksonville Beach Florida United States 32250
5 Baptist Heart Specialists Jacksonville Florida United States 32207
6 Institute of Cardiovascular Research Ocala Florida United States 34471
7 Research Physicians Network Alliance Orlando Florida United States 32825
8 Study Site Saint Petersburg Florida United States 33709
9 Fox Valley Clinical Research Center Aurora Illinois United States 60506
10 Chicago Medical Research, LLC Hazel Crest Illinois United States 60429
11 Unity Point Health-Methodist Peoria Illinois United States 61602
12 Cardiovascular Research of Northwest Indiana, LLC Munster Indiana United States 46321
13 Beacon Medical Group clinical Research South Bend Indiana United States 26554
14 Saint Joseph London London Kentucky United States 40741
15 Massachusetts General Hospital Boston Massachusetts United States 02114
16 Covenant Medical Center, Inc. Saginaw Michigan United States 48602
17 Jackson Heart Clinic Jackson Mississippi United States 39216
18 Saint Luke's Hospital of Kansas City Kansas City Missouri United States 64111
19 SSM Health Heart & Vascular Lake Saint Louis Missouri United States 63367
20 St. Louis Heart and Vascular Saint Louis Missouri United States 63136
21 Hackensack Meridian Health Hackensack New Jersey United States 07601
22 AtlantiCare Regional Medical Center Pomona New Jersey United States 08240
23 Lourdes Cardiology Services Voorhees New Jersey United States 08043
24 Trinity Medical Center Buffalo New York United States 14215
25 SJH Cardiology Liverpool New York United States 13088
26 UNC Chapel Hill Chapel Hill North Carolina United States 27599
27 City Cardiology Associates Barberton Ohio United States 44203
28 Drexel University Philadelphia Pennsylvania United States 19102
29 Temple University Hospital Philadelphia Pennsylvania United States 19140
30 Guthrie Medical Group, P.C. Sayre Pennsylvania United States 18840
31 Carolina Heart Specialists Lancaster South Carolina United States 29720
32 Sanford Health Sioux Falls South Dakota United States 57104
33 Methodist University Hospital (MUH) and Methodist OliveBranch (MOB) Memphis Tennessee United States 38104
34 Methodist South (MS) University Hospital Memphis Tennessee United States 38116
35 Parkway Cardiology Oak Ridge Tennessee United States 37830
36 Texas Health Research & Education Institute Dallas Texas United States 75231
37 Mission Research Insitute New Braunfels Texas United States 78130
38 Providence Health Center Waco Texas United States 76712
39 St. Mary's Medical Center Huntington West Virginia United States 25702
40 Ordensklinikum Linz GmbH/Elisabethinen Linz Austria 4020
41 Medizinische Universitätsklinik Wien Vienna Austria
42 Centre Hospitalier Sud Francilien Corbeil-Essonnes France 91106
43 CHU de Grenoble site Nord- Hopital Albert Michallon Grenoble France 38043
44 CHU de Clermont-Ferrand- Hopital Albert Michallon Grenoble France 63003
45 Hopital Europeen Georges Pompidou Paris France 75015
46 CHU Pontchaillou Rennes France 35033
47 Clinique Pasteur Toulouse France 31076
48 Amper Kliniken AG, Heliios Amper-Klinikum Dachau Dachau Bavaria Germany 85221
49 Klinik u. Polikllinik Fur Innere Med. II Kardiologie Regensburg Bayern Germany 93042
50 Schwarzwald-Baar Klinik Villingen-Schwenningen Deutschland Germany 78052
51 Elisabeth-Krankenhaus Essen NRW Germany 45138
52 Klinikum Augsburg Augsburg Germany 86156
53 Herz- und Gefäßklinik Bad Neustadt Bad Neustadt an der Saale Germany 97616
54 Asklepios Klinik Barmbek Barmbek Germany 22291
55 Charité Universitätsmedizin Berlin Berlin Germany
56 St. Vinzenz Hospital Cologne Germany 50733
57 Universitaetsklinikum Duesseldorf Duesseldorf Germany 40225
58 UKGM, Standort Giessen Giessen Germany 35392
59 Asklepios Harzklinik Goslar Goslar Germany 38642
60 Universitatsklinikum Halle Halle Germany 06120
61 Asklepios Klinik Wandsbek Hamburg Germany 22043
62 Kardiologie, Asklepios Klinik St. Georg Hamburg Germany
63 Medizinische Hochschule Hannover Hannöver Germany 30625
64 Herzzentrum Leipzig GmbH Leipzig Germany 04289
65 Klinikum Ludenscheid Ludenscheid Germany 58515
66 Katholisches Klinikum Lunen Lunen Germany 44534
67 Universitätsklinikum Ulm Ulm Germany

Sponsors and Collaborators

  • Zoll Medical Corporation

Investigators

  • Study Director: Mike Osz, Director, Clinical Operations

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT03016754
Other Study ID Numbers:
  • 90D0109
First Posted:
Jan 11, 2017
Last Update Posted:
Jun 9, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Zoll Medical Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 9, 2022