Clinical trial NCT04096040: Benefits of Microcor in Ambulatory Decompensated Heart Failure
Official title: Benefits of Microcor 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: 2019-09-19
Enrollment: 265
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: To assess investigator engagement of μCor system data in the context of heart failure management. The μCor system includes a sensor and wearable patch for fluid management.

Detailed description: Subjects meeting the inclusion/exclusion criteria will wear the μCor for up to 90 days.

During the study, face to face follow up will occur every 30 days. For all subjects, each scheduled clinic visit will include assessment of cardiac signs, symptoms, and any relevant clinically actionable events.

The subject will be given a daily diary to track symptoms, 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.

The subject's health care provider team will receive the μCor data through access to a clinical tool interface. The clinical tool will send data updates that are dependent on the μCor data trends. The data updates will allow the health care provider team to take action when the data indicate worsening heart failure, within the context of standard of care medical practice and patient specific parameters. Weekly data reports will be delivered to the investigators.

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.

Eligibility criteria: Inclusion Criteria:

* 4.1.1 Subjects hospitalized for acute decompensated heart failure and enrolled in the study within 10 days post-hospital discharge.
* 4.1.2 Subjects who have had an acute heart failure event requiring medical management in the previous 180 days of index hospitalization admission. This acute heart failure event admission must be at least 2 weeks apart from the event admission in 4.1.1
* 4.1.3 Subjects 21 years of age or older on the day of screening.

Exclusion Criteria:

* 4.2.1 Subjects who are wearing the wearable cardioverter defibrillator (WCD)
* 4.2.2 Subjects not expected to survive one year from enrollment from non-cardiac disease.
* 4.2.3 Subjects with skin allergy or sensitivity to medical adhesives.
* 4.2.4 Subjects anticipated to start dialysis within 90 days.
* 4.2.5 Subjects currently implanted with an subcutaneous implantable cardio defibrillator (S-ICD) system.
* 4.2.6 Subjects who received a percutaneous coronary intervention (PCI) less than 24 hours after onset of heart failure related symptoms during index hospitalization.
* 4.2.7 Subjects who are unable to participate in all follow up visits.
* 4.2.8 Subjects participating in research other than a registry at the time of enrollment.
* 4.2.9 Subjects currently implanted with a Left Ventricular Assist Device (LVAD).
* 4.2.10 Subjects with self-reported pregnancy.
* 4.2.11 Subjects currently being actively managed with any device based remote HF monitoring.

Primary outcomes:
measure: Number of Data Updates Received by the uCor Subject Management System
timeFrame: 90 days
measure: Approximate Time Spent Reviewing Data Reports Assessment Across Sites (PO 2: Part 1/2)
timeFrame: 90 days
measure: Approximate Time Spent Reviewing Data Reports Assessment Within Sites (PO 2: Part 2/2)
timeFrame: 90 days
measure: The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 1/3)
timeFrame: 90 days
measure: The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 2/3)
timeFrame: 90 days
measure: The Number of Medication Changes(MC) and Lifestyle Modifications(LS) Recommended to the Subject Based on Evaluating μCor Data and Symptoms (PO 3: Part 3/3)
timeFrame: 90 days
measure: The Number of Medication Changes Based on Subject Incidental Findings
timeFrame: 90 days
measure: Number of Times High μCor Measurements Were Reduced Below Threshold Levels After Medication Was Titrated or Lifestyle Modifications Were Recommended
timeFrame: 90 days
Secondary outcomes:
measure: Strength of Association Between μCor Measurements and Clinically Related Heart Failure Events.
timeFrame: 90 days
measure: Strength of Association Between μCor Measurements and Subject Reported Symptoms
timeFrame: 90 days
measure: Correlations Between uCor Measurements and Patient Reported Symptoms: Mild/Severe Symptoms
timeFrame: 90 days
measure: Hospital Readmission Rate, Physician Visit Rate, and Outpatient Clinic Visit Rate During the Study Period
timeFrame: 90 days
measure: Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Mortality Data
timeFrame: 6 months and 1 year
measure: Mortality Rate, Cause of Death, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Cause of Death
timeFrame: 6 months and 1 year
measure: Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Quality of Life Data
timeFrame: 6 months and 1 year
measure: Mortality Rate, Heart Failure Related Events, Quality of Life (QoL) and Healthcare Utilization Data at 6 Months and One Year Post Enrollment: Healthcare Utilization Data
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Sheffield
country: United States
facility: SYED Research Consultants LLC
state: Alabama
city: El Cajon
country: United States
facility: TriWest Research
state: California
city: Inglewood
country: United States
facility: Zillan Clinical Research
state: California
city: Los Angeles
country: United States
facility: Axis Clinical Trials
state: California
city: Mission Hills
country: United States
facility: InvivoCure LLC
state: California
city: San Diego
country: United States
facility: ACRC Studies
state: California
city: Aventura
country: United States
facility: Aventura Clinical Research LLC
state: Florida
city: Davenport
country: United States
facility: Accel Research Sites - Guardian
state: Florida
city: DeLand
country: United States
facility: Accel Research Sites- Daytona Heart Group
state: Florida
city: Deltona
country: United States
facility: Accel Research Sites - Guardian Winter Park
state: Florida
city: Fort Lauderdale
country: United States
facility: Holy Cross Hospital, Medical Group, Cardiology Associates
state: Florida
city: Hialeah
country: United States
facility: Elite Cardiac Research Center
state: Florida
city: Hialeah
country: United States
facility: Inpatient Research Clinic
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research
state: Florida
city: Miami
country: United States
facility: Westchester Research Center at Westchester General Hospital
state: Florida
city: North Miami
country: United States
facility: Miramax Clinical Research Inc
state: Florida
city: Ocala
country: United States
facility: Ocala Cardiovascular Research
state: Florida
city: Orlando
country: United States
facility: Accel Research Sites
state: Florida
city: Tamarac
country: United States
facility: DBC Research
state: Florida
city: Winter Haven
country: United States
facility: Winter Haven Hospital - BayCare Health System
state: Florida
city: Winter Park
country: United States
facility: Accel Research Sites - Guardian Winter Park
state: Florida
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Columbus
country: United States
facility: Columbus Cardiology Associates
state: Georgia
city: Eatonton
country: United States
facility: Accel Research Sites - Lake County Medical Group
state: Georgia
city: Quincy
country: United States
facility: Quincy Medical Group
state: Illinois
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana, LLC
state: Indiana
city: Richmond
country: United States
facility: Reid Physician Associates
state: Indiana
city: South Bend
country: United States
facility: Beacon Medical Group
state: Indiana
city: Louisville
country: United States
facility: Norton Heart Specialists
state: Kentucky
city: Owensboro
country: United States
facility: Research Integrity, LLC
state: Kentucky
city: Hammond
country: United States
facility: Heart Clinic of Hammond
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Center for Thrombosis Reserach and Drug Development
state: Maryland
city: Pembroke Hills
country: United States
facility: Intervent Clinical Research Center
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Rochester
country: United States
facility: Ascension Providence Rochester Hospital
state: Michigan
city: Saginaw
country: United States
facility: Ascension St. Mary's Research Institute
state: Michigan
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Lee's Summit
country: United States
facility: Kansas City Cardiology
state: Missouri
city: Saint Louis
country: United States
facility: Gateway Cardiovascular Research Center, Inc
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular
state: Missouri
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: Omaha
country: United States
facility: Methodist Physicians Clinical Heart Consultants
state: Nebraska
city: Cherry Hill
country: United States
facility: Virtua Health
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Jersey Shore University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: BronxCare Health System at BronxCare Hospital Center
state: New York
city: Cooperstown
country: United States
facility: Bassett Medical Center
state: New York
city: Rosedale
country: United States
facility: Laurelton Heart Specialist
state: New York
city: Charlotte
country: United States
facility: Macklenberg Heart Specialists / Focus Clinical Research Solutions
state: North Carolina
city: Springfield
country: United States
facility: Heart House Research Foundation
state: Ohio
city: Toledo
country: United States
facility: Mercy Health St. Vincent Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Newtown
country: United States
facility: Mercer Bucks Cardiology at Jefferson Health
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Cardiovascular Institute
state: Pennsylvania
city: Smithfield
country: United States
facility: Frontier Clinical Research, LLC
state: Pennsylvania
city: Lancaster
country: United States
facility: Carolina Heart Specialists
state: South Carolina
city: Knoxville
country: United States
facility: Knoxville HMA Cardiology, PPM, LLC
state: Tennessee
city: Allen
country: United States
facility: North Texas Research Associates
state: Texas
city: Cypress
country: United States
facility: North Houston Cardiology Center
state: Texas
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
city: McKinney
country: United States
facility: North Texas Research Associates
state: Texas
city: McKinney
country: United States
facility: Texas Institute of Cardiology
state: Texas
city: New Braunfels
country: United States
facility: Mission Research Institue
state: Texas
city: Webster
country: United States
facility: Bay Area Heart
state: Texas
city: Lynchburg
country: United States
facility: Stroobants Cardiovascular Center
state: Virginia
city: Puyallup
country: United States
facility: Pulse Heart Institute
state: Washington
city: Klagenfurt
country: Austria
facility: Klinikum Klagenfurt am Wörthersee
city: Wien
country: Austria
facility: Klinik Favoriten
city: Lille
country: France
facility: Centre Hospitalier Régional Universitaire de Lille - Hôpital Cardiologique
city: Montpellier
country: France
facility: CHU Montpellier - Hopital Arnaud de Villeneuve
city: Montpellier
country: France
facility: Chu Montpellier - Hopital Arnaud de Villeneuve
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou - Centre d'Investigations Cliniques - Pôle D - étage 5
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus HH
state: GG
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Frankfort
country: Germany
facility: Universitätsklinikum Frankfurt
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Hamburg
country: Germany
facility: Albertinen Krankenhaus Hamburg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig, Universitätsklinik für Kardiologie Abteilung Rhythmologie
Study officials:
affiliation: Zoll Medical Corporation
name: Mike Osz
role: STUDY_DIRECTOR
References: