Clinical trial NCT03016754: Heart Failure Optimization Study
Official title: Heart Failure Optimization Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sudden Cardiac Death
Sudden Cardiac Arrest
Heart Failure
Heart Failure Low Output
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)
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 602
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Patients With LVEF Recovery at Day 90 and 180
timeFrame: 180 days
measure: Percentage of Study Subjects Reaching Target Doses of Guideline Directed Medical Therapy (GDMT)
timeFrame: 180 days
Secondary outcomes:
measure: All Subjects With Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias During WCD Use
timeFrame: 360 days
measure: All Sustained Ventricular Tachycardia (VT)/Ventricular Fibrillation (VF) Arrhythmias Events During WCD Use
timeFrame: 360 days
measure: Percentage of All Patients Having Other Arrhythmias
timeFrame: 180 days
measure: Efficacy in Treating Ventricular Arrhythmias
timeFrame: 180 days
measure: Mortality Analysis
timeFrame: 0 to180, 0 to 270, and 0 to 360 days, or >360 days (up to 14 months)
measure: Healthcare utilization_type
timeFrame: 360 days
measure: Healthcare utilization_length of Use
timeFrame: 360 days
Other outcomes:
measure: Complications From Extended Use
timeFrame: 360 days
Locations:
city: Birmingham
country: United States
facility: UAB Division of Cardiovascular Disease
state: Alabama
city: West Hills
country: United States
facility: Study Site
state: California
city: Fernandina Beach
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Jacksonville Beach
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Jacksonville
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Ocala
country: United States
facility: Institute of Cardiovascular Research
state: Florida
city: Orlando
country: United States
facility: Research Physicians Network Alliance
state: Florida
city: Saint Petersburg
country: United States
facility: Study Site
state: Florida
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center
state: Illinois
city: Hazel Crest
country: United States
facility: Chicago Medical Research, LLC
state: Illinois
city: Peoria
country: United States
facility: Unity Point Health-Methodist
state: Illinois
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana, LLC
state: Indiana
city: South Bend
country: United States
facility: Beacon Medical Group clinical Research
state: Indiana
city: London
country: United States
facility: Saint Joseph London
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Saginaw
country: United States
facility: Covenant Medical Center, Inc.
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Lake Saint Louis
country: United States
facility: SSM Health Heart & Vascular
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Lourdes Cardiology Services
state: New Jersey
city: Buffalo
country: United States
facility: Trinity Medical Center
state: New York
city: Liverpool
country: United States
facility: SJH Cardiology
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Barberton
country: United States
facility: City Cardiology Associates
state: Ohio
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group, P.C.
state: Pennsylvania
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Sioux Falls
country: United States
facility: Sanford Health
state: South Dakota
city: Memphis
country: United States
facility: Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)
state: Tennessee
city: Memphis
country: United States
facility: Methodist South (MS) University Hospital
state: Tennessee
city: Oak Ridge
country: United States
facility: Parkway Cardiology
state: Tennessee
city: Dallas
country: United States
facility: Texas Health Research & Education Institute
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Insitute
state: Texas
city: Waco
country: United States
facility: Providence Health Center
state: Texas
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH/Elisabethinen
city: Vienna
country: Austria
facility: Medizinische Universitätsklinik Wien
city: Corbeil-Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
city: Grenoble
country: France
facility: CHU de Grenoble site Nord- Hopital Albert Michallon
city: Grenoble
country: France
facility: CHU de Clermont-Ferrand- Hopital Albert Michallon
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou
city: Rennes
country: France
facility: CHU Pontchaillou
city: Toulouse
country: France
facility: Clinique Pasteur
city: Dachau
country: Germany
facility: Amper Kliniken AG, Heliios Amper-Klinikum Dachau
state: Bavaria
city: Regensburg
country: Germany
facility: Klinik u. Polikllinik Fur Innere Med. II Kardiologie
state: Bayern
city: Villingen-Schwenningen
country: Germany
facility: Schwarzwald-Baar Klinik
state: Deutschland
city: Essen
country: Germany
facility: Elisabeth-Krankenhaus
state: NRW
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Bad Neustadt an der Saale
country: Germany
facility: Herz- und Gefäßklinik Bad Neustadt
city: Barmbek
country: Germany
facility: Asklepios Klinik Barmbek
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Cologne
country: Germany
facility: St. Vinzenz Hospital
city: Duesseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf
city: Giessen
country: Germany
facility: UKGM, Standort Giessen
city: Goslar
country: Germany
facility: Asklepios Harzklinik Goslar
city: Halle
country: Germany
facility: Universitatsklinikum Halle
city: Hamburg
country: Germany
facility: Asklepios Klinik Wandsbek
city: Hamburg
country: Germany
facility: Kardiologie, Asklepios Klinik St. Georg
city: Hannöver
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Ludenscheid
country: Germany
facility: Klinikum Ludenscheid
city: Lunen
country: Germany
facility: Katholisches Klinikum Lunen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: Director, Clinical Operations
name: Mike Osz
role: STUDY_DIRECTOR
References: