Last updated on July 2019

Benefits of Cor in Ambulatory Decompensated Heart Failure


Brief description of study

Subjects meeting the inclusion/exclusion criteria will wear the Cor 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 Cor wear, and any health care utilization since the end of Cor wear.

Detailed Study Description

Subjects meeting the inclusion/exclusion criteria will wear Cor 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 Cor during hospital discharge or within a clinic visit that has occurred within 10 days of a heart failure related hospitalization. The Cor 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 Cor 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 Cor 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 Cor 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.

Clinical Study Identifier: NCT03476187

Find a site near you

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Nova Clinical Research LLC

Bradenton, FL United States
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Holy Cross Medical Group

Fort Lauderdale, FL United States
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Baptist Heart Specialists

Jacksonville, FL United States
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Northside Hospital

Saint Petersburg, FL United States
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The Loretto Hospital

Chicago, IL United States
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Trinity Medical WNY

Buffalo, NY United States
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OUHSC

Oklahoma City, OK United States
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UMPC Hamot

Erie, PA United States
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PharmaTex Research

Amarillo, TX United States
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Texas Cardiovascular Institute

Fort Worth, TX United States
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CardioVogage

McKinney, TX United States
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Chippenham Hospital

Richmond, VA United States
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Henrico Doctors Hospital

Richmond, VA United States
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Nebraska Heart Institute

Grand Island, NE United States
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Nebraska Heart Institute

Lincoln, NE United States
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The Jackson Clinic, PA

Jackson, TN United States
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Marshall Cardiology

Huntington, WV United States
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Recruitment Status: Open


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