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Benefits of µCor in Ambulatory Decompensated Heart Failure (BMADHF)

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ClinicalTrials.gov Identifier: NCT03476187
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Heart Failure Device: µCor Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Benefits of µCor in Ambulatory Decompensated Heart Failure
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: µCor wearers
Wear the µCor device
Device: µCor
Monitor with µCor




Primary Outcome Measures :
  1. Correlation of µCor measured thoracic fluid index to heart failure related clinical events [ Time Frame: 3-6 months ]
    Reading include: thoracic fluid index.


Secondary Outcome Measures :
  1. Correlation of cardiac rhythm µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: cardiac rhythm

  2. Correlation of respiration rate µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: respiration rate

  3. Correlation of posture µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: posture

  4. Correlation of physical activity µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: physical activity

  5. Correlation of hospitalizations µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: hospitalizations

  6. Correlation of medication changes µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: medication changes

  7. Correlation of symptom changes µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: symptom changes



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476187


Contacts
Contact: Mike A. Osz, B.Sc. (Hons) +1-412-968-3472 mosz@zoll.com
Contact: Leah Zeiler, MS +1-412-968-3518 lzeiler@zoll.com

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Coglianese, MD         
United States, Texas
Texas Institute of Cardiology Recruiting
McKinney, Texas, United States, 75071
Contact: Wahid, MD         
Sponsors and Collaborators
Zoll Medical Corporation
Investigators
Study Director: Steven J. Szymkiewicz, MD Zoll Medical Corporation

Responsible Party: Zoll Medical Corporation
ClinicalTrials.gov Identifier: NCT03476187     History of Changes
Other Study ID Numbers: 90D0182
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases