Benefits of µCor in Ambulatory Decompensated Heart Failure

NCT ID: NCT03476187

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 257 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-17
• Study Completion Date: 2024-04-09

Brief Summary

Subjects meeting the inclusion/exclusion criteria will wear the µCor for at least 90 days. During the study, clinic follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac symptoms and any relevant clinically actionable events. The subject will be given a daily diary to track symptoms, unplanned hospital visits, medication changes, and all other heart failure related clinical events. Weekly phone calls to the subject will be given throughout the duration of the study to remind the patient to use the subject diary and to collect and record heart failure related clinical events. Subjects will be contacted six months and one year from initial enrollment to assess the vital status of the subject, any heart failure related clinical events since the end of µCor wear, and any health care utilization since the end of µCor wear.

Detailed Description

Subjects meeting the inclusion/exclusion criteria will wear µCor for 90 days from the day of fitting. 500 total patients will be enrolled. There will be an interim analysis when the 200th subject has finished the study in the study to assess for distribution of patients with reduced and preserved LVEF.

Subjects will be fitted with µCor during hospital discharge or within a clinic visit that has occurred within 10 days of a heart failure related hospitalization. The µCor fitting will mark day 0 of the study. An LVEF measurement will be recorded during enrollment or within 30 days post enrollment if an LVEF measurement has not been recorded within 30 days prior to enrollment. An investigator assessment will be performed during all clinic visits. The assessment template is shown in Appendix A.

Subjects will be given a diary at enrollment that will ask them to rate their degree of specific symptoms of heart failure such as shortness of breath and fatigue as well as mark any heart failure related clinical events or medication changes that have occurred since the last entry.

Study follow up visits will occur at day 30, day 60, and day 90. During follow up visits the subjects will be asked about any heart failure related clinical events or change in symptoms that have occurred since the last follow up. The subject will receive a study based weekly phone call asking the subject about any recent heart failure related clinical events or change in heart failure symptoms. During the weekly phone call the subject will be reminded to fill out the daily diary. No phone calls will be given on the week where there is a study follow up visit. There will be 9 total phone calls.

During the Day 90 visit, the subject will be given the option to continue wearing the µCor for an additional 90 days. Furthermore, if the subject experienced a heart failure related clinical event within the initial 90 days of wear, the subject will be given the option of wearing the µCor for 30 days following the heart failure event. .If the subject chooses additional wear time, weekly phone calls and monthly visits will be structured identical to that of the main study period. The µCor will be returned at end of use.

There will be a follow up at six months and one year post enrollment to document mortality data, heart failure related clinical events, and health care utilization data.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

µCor wearers

Wear the µCor device

Group Type: EXPERIMENTAL

µCor

Intervention Type: DEVICE

Monitor with µCor

Interventions

µCor

Monitor with µCor

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects either hospitalized for decompensated systolic, diastolic, or combined heart failure or subjects presenting at an outpatient clinic with a history of hospital discharge for decompensated systolic, diastolic, or combined heart failure within the previous 10 days.
• All subjects must be 21 years of age or older on the day of screening.

Exclusion Criteria

• Subjects who are wearing the wearable cardioverter defibrillator (WCD)
• Subjects not expected to survive one year from enrollment from non-cardiac disease.
• Subjects with skin allergy or sensitivity to medical adhesives.
• Subjects anticipated to start dialysis within 90 days.
• Subjects currently implanted with an S-ICD system.
• Subjects whose primary diagnosis on hospital admission was Acute Coronary Syndrome (ACS) STEMI/NSTEMI rather than heart failure exacerbation.
• Subjects who are unable to participate in all follow up visits.
• Subjects participating in any other research at time of enrollment.
• Subjects currently implanted with an LVAD.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zoll Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven J. Szymkiewicz, MD

Role: STUDY_DIRECTOR

Zoll Medical Corporation

Locations

Mobile Heart Specialists, PC

Mobile, Alabama, United States

University Hospital

Mobile, Alabama, United States

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Cardiovascular Innovation and Research Center, Inc.

Long Beach, California, United States

Los Alamitos Cardiovascular

Los Alamitos, California, United States

Nova Clinical Research LLC

Bradenton, Florida, United States

South Palm Cardiovascular Research Institute

Delray Beach, Florida, United States

Holy Cross Medical Group

Fort Lauderdale, Florida, United States

The Cardiac and Vascular Institute Research Foundation

Gainesville, Florida, United States

Baptist Heart Specialists

Jacksonville, Florida, United States

The Heart Institute at Largo

Largo, Florida, United States

Mount Sinai Medical Center

Miami Beach, Florida, United States

Cardiovascular Institute of Central Florida

Ocala, Florida, United States

Northside Hospital

St. Petersburg, Florida, United States

University of South Florida Dept of Cardiovascular Sciences

Tampa, Florida, United States

Cardiology Practice Tampa

Tampa, Florida, United States

Cardiovascular Consultants of South Georgia

Thomasville, Georgia, United States

Fox Valley Clinical Research Center

Aurora, Illinois, United States

The Loretto Hospital

Chicago, Illinois, United States

Chicago Medical Research LLC

Hazel Crest, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Unity Point Health Cardiovascular Services

Peoria, Illinois, United States

DuPage Medical Group

Winfield, Illinois, United States

Grace Research LLC

Bossier City, Louisiana, United States

Clinical Trials of America, LLC

Monroe, Louisiana, United States

Clinical Trials of America, LLC

West Monroe, Louisiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Cardiology Institute of Michigan

Flint, Michigan, United States

Hennepen Healthcare Research Institute

Minneapolis, Minnesota, United States

Nebraska Heart Institute

Grand Island, Nebraska, United States

Nebraska Heart Institute

Lincoln, Nebraska, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

New Jersey Heart

Linden, New Jersey, United States

AtlantiCare Regional Medical Center

Pomona, New Jersey, United States

Trinity Medical WNY

Buffalo, New York, United States

SJH Cardiology Associates

Liverpool, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

East Carolina Heart Institute

Greenville, North Carolina, United States

NC Heart & Vascular Research

Raleigh, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

OUHSC

Oklahoma City, Oklahoma, United States

UMPC Hamot

Erie, Pennsylvania, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

The Guthrie Clinic

Sayre, Pennsylvania, United States

Cardiology Consultants of Philadelphia

Yardley, Pennsylvania, United States

Palmetto Health Advanced Heart Health Center

Columbia, South Carolina, United States

The Jackson Clinic, PA

Jackson, Tennessee, United States

PharmaTex Research

Amarillo, Texas, United States

JPS Health Network

Fort Worth, Texas, United States

Texas Cardiovascular Institute

Fort Worth, Texas, United States

Northwest Houston Cardiology

Houston, Texas, United States

CardioVogage

McKinney, Texas, United States

Texas Institute of Cardiology

McKinney, Texas, United States

Riverside Hospital Inc.

Newport News, Virginia, United States

Chippenham Hospital

Richmond, Virginia, United States

Henrico Doctors Hospital

Richmond, Virginia, United States

Marshall Cardiology

Huntington, West Virginia, United States

Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie

Vienna, , Austria

St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III

Cologne, , Germany

Herzzentrum Leipzig GmbH

Leipzig, , Germany

Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I

Munich, , Germany

Countries

United States; Austria; Germany

References

Boehmer JP, Cremer S, Abo-Auda WS, Stokes DR, Hadi A, McCann PJ, Burch AE, Bonderman D. Impact of a Novel Wearable Sensor on Heart Failure Rehospitalization: An Open-Label Concurrent-Control Clinical Trial. JACC Heart Fail. 2024 Dec;12(12):2011-2022. doi: 10.1016/j.jchf.2024.07.022. Epub 2024 Oct 9.

Reference Type: DERIVED

PMID: 39387771 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

90D0182

Identifier Type: -

Identifier Source: org_study_id