Benefits of µCor in Ambulatory Decompensated Heart Failure
- Conditions
- Heart Failure
- Interventions
- Device: µCor
- Registration Number
- NCT03476187
- Lead Sponsor
- Zoll Medical Corporation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description µCor wearers µCor Wear the µCor device
- Primary Outcome Measures
Name Time Method Correlation of µCor Readings to Heart Failure Related Clinical Events 3 months Definitions:
Daytime: 7:00 AM - 12:00 AM Nighttime: 12:00 AM - 7:00 AM
For each day on which the subject wore the device, the following values were calculated:
Daytime activity: The proportion of minutes while wearing the device that the subject spent active (unitless).
Nighttime heart rate: The median heart rate while wearing the device during the night (beats/min)
Thoracic fluid index: The median proportion of ratio of radiofrequency-measured lung fluid readings compared to the subject's baseline (unitless).
Nighttime posture: The median pitch angle while wearing the device during the night (degrees, where 0 is the horizontal).
Nighttime respiration: The median respiration rate while wearing the device during the night (breaths/min)
HF event: a hospitalization primarily due to heart failureCorrelation of μCor Readings to Heart Failure Related Clinical Events 3 months HF Event: a hospitalization primarily due to heart failure within 90 days. Time window: The 7 days prior to the 1st heart failure hospitalization, or the final 7 days of device wear if no HF event occurred.
- Secondary Outcome Measures
Name Time Method Establishment of Rate of Occurrence of VT/VF Episodes and Arrhythmic Death in Subjects Baseline, 90 days, 1 YR Rate of occurrence of VT/VF episodes at the time of enrollment in the study and rate of occurrence of arrhythmic death in subjects at 90 days and 1 year.
Correlation Between μCor Measurements and Subject Reported Symptoms - Area Under Curve 3 months During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\]. Each day that the subject wore the device, a daily median was calculated for the following measures: \[thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)\]. Nighttime was defined as 12:00 AM - 7:00 AM.
Correlation Between μCor Measurements and Subject Reported Symptoms - Number of Mild/Severe Symptoms 3 months During office visits at months 1, 2, and 3, subjects reported their degrees of dyspnea, orthopnea, and fatigue on the following scale: \[none, seldom, frequent, continuous\]. Each day that the subject wore the device, a daily median was calculated for the following measures: \[thoracic fluid index (TFI), nighttime heart rate (HR), nighttime respiration rate (RR)\]. Nighttime was defined as 12:00 AM - 7:00 AM.
Frequency of Subject Reported Symptoms 3 months During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the number of times that subjects reported each of these two symptoms.
Timing of Subject Reported Symptoms 3 months During weekly phone calls and monthly office visits, subjects reported whether they experienced new arrhythmia and/or heart failure symptoms. Results indicate the median number of weeks until a subject's first symptom report of each type.
Severity of Subject Reported Symptoms 3 months Each subject was expected to undergo an in-person office visit at the site on months 0, 1, 2, and 3 in which they reported the severity of their heart failure symptoms. Results indicate the number of subjects reporting each severity level of each symptom at each office visit.
Hospital Readmission Rate During the Study Period 3 months During weekly phone calls and monthly office visits, subjects reported whether they experienced a new hospitalization since their last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not.
Hospital Readmission Rate During Previous 90 Days Prior to Enrollment in Study 3 months At the time of enrollment, subjects reported how many hospitalizations they experienced in the 90 days prior to enrollment. Results indicate the median number of hospitalizations reported per subject in this time window.
Mortality, Heart Failure Related Events, and Health Care Utilization Data at Six Months and One Year Post Enrollment 6 months and 1 year During weekly phone calls, monthly office visits, the 6-month phone call, and the 1-year phone call, subjects reported whether they experienced a hospitalization, ER visit, or unplanned doctor's office visit since the last call/visit. An adjudication committee of physicians determined whether each hospitalization was due to HF or not. On each subject's final date of study participation, their survival status was recorded.
Trial Locations
- Locations (59)
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Mobile Heart Specialists, PC
🇺🇸Mobile, Alabama, United States
University Hospital
🇺🇸Mobile, Alabama, United States
Cardiovascular Innovation and Research Center, Inc.
🇺🇸Long Beach, California, United States
NEA Baptist Clinic
🇺🇸Jonesboro, Arkansas, United States
Los Alamitos Cardiovascular
🇺🇸Los Alamitos, California, United States
Nova Clinical Research LLC
🇺🇸Bradenton, Florida, United States
Holy Cross Medical Group
🇺🇸Fort Lauderdale, 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
🇺🇸Saint Petersburg, Florida, United States
Fox Valley Clinical Research Center
🇺🇸Aurora, Illinois, United States
Cardiovascular Consultants of South Georgia
🇺🇸Thomasville, Georgia, 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
🇺🇸West Monroe, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Cardiology Institute of Michigan
🇺🇸Flint, Michigan, United States
Nebraska Heart Institute
🇺🇸Lincoln, Nebraska, 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
NC Heart & Vascular Research
🇺🇸Raleigh, North Carolina, United States
East Carolina Heart Institute
🇺🇸Greenville, North Carolina, United States
UMPC Hamot
🇺🇸Erie, Pennsylvania, United States
The Guthrie Clinic
🇺🇸Sayre, Pennsylvania, United States
The Jackson Clinic, PA
🇺🇸Jackson, Tennessee, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Cardiology Consultants of Philadelphia
🇺🇸Yardley, Pennsylvania, United States
Palmetto Health Advanced Heart Health Center
🇺🇸Columbia, South Carolina, United States
PharmaTex Research
🇺🇸Amarillo, Texas, United States
Texas Cardiovascular Institute
🇺🇸Fort Worth, Texas, United States
Northwest Houston Cardiology
🇺🇸Houston, Texas, United States
CardioVogage
🇺🇸McKinney, Texas, United States
JPS Health Network
🇺🇸Fort Worth, Texas, United States
Texas Institute of Cardiology
🇺🇸McKinney, Texas, United States
Riverside Hospital Inc.
🇺🇸Newport News, Virginia, United States
Marshall Cardiology
🇺🇸Huntington, West Virginia, United States
St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III
🇩🇪Cologne, Germany
Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I
🇩🇪Munich, Germany
Herzzentrum Leipzig GmbH
🇩🇪Leipzig, Germany
Hennepen Healthcare Research Institute
🇺🇸Minneapolis, Minnesota, United States
Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie
🇦🇹Vienna, Austria
University of Rochester Medical Center
🇺🇸Rochester, New York, United States
OUHSC
🇺🇸Oklahoma City, Oklahoma, United States
South Palm Cardiovascular Research Institute
🇺🇸Delray Beach, Florida, United States
University of South Florida Dept of Cardiovascular Sciences
🇺🇸Tampa, Florida, United States
Cardiology Practice Tampa
🇺🇸Tampa, Florida, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Chippenham Hospital
🇺🇸Richmond, Virginia, United States
The Cardiac and Vascular Institute Research Foundation
🇺🇸Gainesville, Florida, United States
Henrico Doctors Hospital
🇺🇸Richmond, Virginia, United States