Clinical trial NCT03476187: Benefits of µCor in Ambulatory Decompensated Heart Failure
Official title: Benefits of µCor in Ambulatory Decompensated Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2018-03-23
Enrollment: 257
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Correlation of μCor Readings to Heart Failure Related Clinical Events
timeFrame: 3 months
measure: Correlation of µCor Readings to Heart Failure Related Clinical Events
timeFrame: 3 months
Secondary outcomes:
measure: Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects
timeFrame: Baseline, 90 days, 1 YR
measure: Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve
timeFrame: 3 months
measure: Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms
timeFrame: 3 months
measure: Frequency of Subject Reported Symptoms
timeFrame: 3 months
measure: Timing of Subject Reported Symptoms
timeFrame: 3 months
measure: Severity of Subject Reported Symptoms
timeFrame: 3 months
measure: Hospital Readmission Rate During the Study Period
timeFrame: 3 months
measure: Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study
timeFrame: 3 months
measure: Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study
timeFrame: 3 months
measure: Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Mobile Heart Specialists, PC
state: Alabama
city: Mobile
country: United States
facility: University Hospital
state: Alabama
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Long Beach
country: United States
facility: Cardiovascular Innovation and Research Center, Inc.
state: California
city: Los Alamitos
country: United States
facility: Los Alamitos Cardiovascular
state: California
city: Bradenton
country: United States
facility: Nova Clinical Research LLC
state: Florida
city: Delray Beach
country: United States
facility: South Palm Cardiovascular Research Institute
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Medical Group
state: Florida
city: Gainesville
country: United States
facility: The Cardiac and Vascular Institute Research Foundation
state: Florida
city: Jacksonville
country: United States
facility: Baptist Heart Specialists
state: Florida
city: Largo
country: United States
facility: The Heart Institute at Largo
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Ocala
country: United States
facility: Cardiovascular Institute of Central Florida
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Tampa
country: United States
facility: University of South Florida Dept of Cardiovascular Sciences
state: Florida
city: Tampa
country: United States
facility: Cardiology Practice Tampa
state: Florida
city: Thomasville
country: United States
facility: Cardiovascular Consultants of South Georgia
state: Georgia
city: Aurora
country: United States
facility: Fox Valley Clinical Research Center
state: Illinois
city: Chicago
country: United States
facility: The Loretto Hospital
state: Illinois
city: Hazel Crest
country: United States
facility: Chicago Medical Research LLC
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Peoria
country: United States
facility: Unity Point Health Cardiovascular Services
state: Illinois
city: Winfield
country: United States
facility: DuPage Medical Group
state: Illinois
city: Bossier City
country: United States
facility: Grace Research LLC
state: Louisiana
city: Monroe
country: United States
facility: Clinical Trials of America, LLC
state: Louisiana
city: West Monroe
country: United States
facility: Clinical Trials of America, LLC
state: Louisiana
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Flint
country: United States
facility: Cardiology Institute of Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Hennepen Healthcare Research Institute
state: Minnesota
city: Grand Island
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Lincoln
country: United States
facility: Nebraska Heart Institute
state: Nebraska
city: Las Vegas
country: United States
facility: University Medical Center of Southern Nevada
state: Nevada
city: Linden
country: United States
facility: New Jersey Heart
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare Regional Medical Center
state: New Jersey
city: Buffalo
country: United States
facility: Trinity Medical WNY
state: New York
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Greenville
country: United States
facility: East Carolina Heart Institute
state: North Carolina
city: Raleigh
country: United States
facility: NC Heart & Vascular Research
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Oklahoma City
country: United States
facility: OUHSC
state: Oklahoma
city: Erie
country: United States
facility: UMPC Hamot
state: Pennsylvania
city: Lancaster
country: United States
facility: Lancaster General Hospital
state: Pennsylvania
city: Sayre
country: United States
facility: The Guthrie Clinic
state: Pennsylvania
city: Yardley
country: United States
facility: Cardiology Consultants of Philadelphia
state: Pennsylvania
city: Columbia
country: United States
facility: Palmetto Health Advanced Heart Health Center
state: South Carolina
city: Jackson
country: United States
facility: The Jackson Clinic, PA
state: Tennessee
city: Amarillo
country: United States
facility: PharmaTex Research
state: Texas
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
city: Fort Worth
country: United States
facility: Texas Cardiovascular Institute
state: Texas
city: Houston
country: United States
facility: Northwest Houston Cardiology
state: Texas
city: McKinney
country: United States
facility: CardioVogage
state: Texas
city: McKinney
country: United States
facility: Texas Institute of Cardiology
state: Texas
city: Newport News
country: United States
facility: Riverside Hospital Inc.
state: Virginia
city: Richmond
country: United States
facility: Chippenham Hospital
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors Hospital
state: Virginia
city: Huntington
country: United States
facility: Marshall Cardiology
state: West Virginia
city: Vienna
country: Austria
facility: Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie
city: Cologne
country: Germany
facility: St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Munich
country: Germany
facility: Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I
Study officials:
affiliation: Zoll Medical Corporation
name: Steven J. Szymkiewicz, MD
role: STUDY_DIRECTOR
References: