Heart Failure Optimization Study

Heart Failure Clinical Trial

— HF-Opt  

Official title:

Heart Failure Optimization Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03016754
• Other study ID #: 90D0109
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: June 1, 2022

Study information

• Verified date: June 2022
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: June 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Heart Arrest
• Heart Failure
• Heart Failure Low Output
• Sudden Cardiac Arrest
• Sudden Cardiac Death

Intervention

Device:
• Wearable Cardioverter Defibrillator
LifeVest Wearable Cardioverter Defibrillator

Locations

Country	Name	City	State
Austria	Ordensklinikum Linz GmbH/Elisabethinen	Linz
Austria	Medizinische Universitätsklinik Wien	Vienna
France	Centre Hospitalier Sud Francilien	Corbeil-Essonnes
France	CHU de Clermont-Ferrand- Hopital Albert Michallon	Grenoble
France	CHU de Grenoble site Nord- Hopital Albert Michallon	Grenoble
France	Hopital Europeen Georges Pompidou	Paris
France	CHU Pontchaillou	Rennes
France	Clinique Pasteur	Toulouse
Germany	Klinikum Augsburg	Augsburg
Germany	Herz- und Gefäßklinik Bad Neustadt	Bad Neustadt an der Saale
Germany	Asklepios Klinik Barmbek	Barmbek
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	St. Vinzenz Hospital	Cologne
Germany	Amper Kliniken AG, Heliios Amper-Klinikum Dachau	Dachau	Bavaria
Germany	Universitaetsklinikum Duesseldorf	Duesseldorf
Germany	Elisabeth-Krankenhaus	Essen	NRW
Germany	UKGM, Standort Giessen	Giessen
Germany	Asklepios Harzklinik Goslar	Goslar
Germany	Universitatsklinikum Halle	Halle
Germany	Asklepios Klinik Wandsbek	Hamburg
Germany	Kardiologie, Asklepios Klinik St. Georg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannöver
Germany	Herzzentrum Leipzig GmbH	Leipzig
Germany	Klinikum Ludenscheid	Ludenscheid
Germany	Katholisches Klinikum Lunen	Lunen
Germany	Klinik u. Polikllinik Fur Innere Med. II Kardiologie	Regensburg	Bayern
Germany	Universitätsklinikum Ulm	Ulm
Germany	Schwarzwald-Baar Klinik	Villingen-Schwenningen	Deutschland
United States	Fox Valley Clinical Research Center	Aurora	Illinois
United States	City Cardiology Associates	Barberton	Ohio
United States	UAB Division of Cardiovascular Disease	Birmingham	Alabama
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Trinity Medical Center	Buffalo	New York
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	Texas Health Research & Education Institute	Dallas	Texas
United States	Baptist Heart Specialists	Fernandina Beach	Florida
United States	Hackensack Meridian Health	Hackensack	New Jersey
United States	Chicago Medical Research, LLC	Hazel Crest	Illinois
United States	St. Mary's Medical Center	Huntington	West Virginia
United States	Jackson Heart Clinic	Jackson	Mississippi
United States	Baptist Heart Specialists	Jacksonville	Florida
United States	Baptist Heart Specialists	Jacksonville Beach	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	SSM Health Heart & Vascular	Lake Saint Louis	Missouri
United States	Carolina Heart Specialists	Lancaster	South Carolina
United States	SJH Cardiology	Liverpool	New York
United States	Saint Joseph London	London	Kentucky
United States	Methodist South (MS) University Hospital	Memphis	Tennessee
United States	Methodist University Hospital (MUH) and Methodist OliveBranch (MOB)	Memphis	Tennessee
United States	Cardiovascular Research of Northwest Indiana, LLC	Munster	Indiana
United States	Mission Research Insitute	New Braunfels	Texas
United States	Parkway Cardiology	Oak Ridge	Tennessee
United States	Institute of Cardiovascular Research	Ocala	Florida
United States	Research Physicians Network Alliance	Orlando	Florida
United States	Unity Point Health-Methodist	Peoria	Illinois
United States	Drexel University	Philadelphia	Pennsylvania
United States	Temple University Hospital	Philadelphia	Pennsylvania
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	Covenant Medical Center, Inc.	Saginaw	Michigan
United States	St. Louis Heart and Vascular	Saint Louis	Missouri
United States	Study Site	Saint Petersburg	Florida
United States	Guthrie Medical Group, P.C.	Sayre	Pennsylvania
United States	Sanford Health	Sioux Falls	South Dakota
United States	Beacon Medical Group clinical Research	South Bend	Indiana
United States	Lourdes Cardiology Services	Voorhees	New Jersey
United States	Providence Health Center	Waco	Texas
United States	Study Site	West Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications from extended use	The safety objectives will be to compare complications from extended use of the WCD with those of the ICD during the study timeframe.	360 days
Primary	Do not require ICD implant	Patient improved (EF >35%), SCD risk deemed to be negligible. These patients will end WCD use and not receive an ICD.	180 days
Primary	Continue WCD use	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.	180 days
Primary	Meet GDMT	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.	180 days
Secondary	Incidence of other arrhythmias	Observe the incidence of other arrhythmias during WCD use, such as asystole and supra-ventricular arrhythmias that are recorded by the device.	180 days
Secondary	Determine the number of ICD treatment shocks	Collect ICD treatment data for those who receive an ICD, and evaluate for appropriateness as assessed by ECG recordings.	180 days
Secondary	Efficacy in ventricular arrhythmias	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.	180 days
Secondary	Mortality following hospital discharge	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.	360 days
Secondary	Cost of healthcare utilization	Assess cost of healthcare utilization (emergency room visits, hospitalizations, doctor visits etc.) on all patients during the period of the study.	360 days