Benefits of µCor in Ambulatory Decompensated Heart Failure

Heart Failure Clinical Trial

— BMADHF  

Official title:

Benefits of µCor in Ambulatory Decompensated Heart Failure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03476187
• Other study ID #: 90D0182
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 25, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: July 2023
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• µCor
Monitor with µCor

Locations

Country	Name	City	State
Austria	Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie	Vienna
Germany	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
United States	PharmaTex Research	Amarillo	Texas
United States	Fox Valley Clinical Research Center	Aurora	Illinois
United States	Grace Research LLC	Bossier City	Louisiana
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Nova Clinical Research LLC	Bradenton	Florida
United States	Trinity Medical WNY	Buffalo	New York
United States	The Loretto Hospital	Chicago	Illinois
United States	Palmetto Health Advanced Heart Health Center	Columbia	South Carolina
United States	South Palm Cardiovascular Research Institute	Delray Beach	Florida
United States	UMPC Hamot	Erie	Pennsylvania
United States	Cardiology Institute of Michigan	Flint	Michigan
United States	Holy Cross Medical Group	Fort Lauderdale	Florida
United States	JPS Health Network	Fort Worth	Texas
United States	Texas Cardiovascular Institute	Fort Worth	Texas
United States	The Cardiac and Vascular Institute Research Foundation	Gainesville	Florida
United States	Nebraska Heart Institute	Grand Island	Nebraska
United States	East Carolina Heart Institute	Greenville	North Carolina
United States	Chicago Medical Research LLC	Hazel Crest	Illinois
United States	Northwest Houston Cardiology	Houston	Texas
United States	Marshall Cardiology	Huntington	West Virginia
United States	The Jackson Clinic, PA	Jackson	Tennessee
United States	Baptist Heart Specialists	Jacksonville	Florida
United States	NEA Baptist Clinic	Jonesboro	Arkansas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	The Heart Institute at Largo	Largo	Florida
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Nebraska Heart Institute	Lincoln	Nebraska
United States	New Jersey Heart	Linden	New Jersey
United States	SJH Cardiology Associates	Liverpool	New York
United States	Cardiovascular Innovation and Research Center, Inc.	Long Beach	California
United States	Los Alamitos Cardiovascular	Los Alamitos	California
United States	Loyola University Medical Center	Maywood	Illinois
United States	CardioVogage	McKinney	Texas
United States	Texas Institute of Cardiology	McKinney	Texas
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Hennepen Healthcare Research Institute	Minneapolis	Minnesota
United States	Mobile Heart Specialists, PC	Mobile	Alabama
United States	University Hospital	Mobile	Alabama
United States	Clinical Trials of America, LLC	Monroe	Louisiana
United States	Riverside Hospital Inc.	Newport News	Virginia
United States	Cardiovascular Institute of Central Florida	Ocala	Florida
United States	OUHSC	Oklahoma City	Oklahoma
United States	Unity Point Health Cardiovascular Services	Peoria	Illinois
United States	AtlantiCare Regional Medical Center	Pomona	New Jersey
United States	NC Heart & Vascular Research	Raleigh	North Carolina
United States	Chippenham Hospital	Richmond	Virginia
United States	Henrico Doctors Hospital	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Northside Hospital	Saint Petersburg	Florida
United States	The Guthrie Clinic	Sayre	Pennsylvania
United States	Cardiology Practice Tampa	Tampa	Florida
United States	University of South Florida Dept of Cardiovascular Sciences	Tampa	Florida
United States	Cardiovascular Consultants of South Georgia	Thomasville	Georgia
United States	Clinical Trials of America, LLC	West Monroe	Louisiana
United States	DuPage Medical Group	Winfield	Illinois
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Cardiology Consultants of Philadelphia	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Countries where clinical trial is conducted

United States,  Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of µCor measured thoracic fluid index to heart failure related clinical events	Reading include: thoracic fluid index.	3-6 months
Secondary	Correlation of cardiac rhythm µCor measurements to heart failure related clinical events	Readings include: cardiac rhythm	3-6 months
Secondary	Correlation of respiration rate µCor measurements to heart failure related clinical events	Readings include: respiration rate	3-6 months
Secondary	Correlation of posture µCor measurements to heart failure related clinical events	Readings include: posture	3-6 months
Secondary	Correlation of physical activity µCor measurements to heart failure related clinical events	Readings include: physical activity	3-6 months
Secondary	Correlation of hospitalizations µCor measurements to heart failure related clinical events	Readings include: hospitalizations	3-6 months
Secondary	Correlation of medication changes µCor measurements to heart failure related clinical events	Readings include: medication changes	3-6 months
Secondary	Correlation of symptom changes µCor measurements to heart failure related clinical events	Readings include: symptom changes	3-6 months