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Trial record 1 of 1 for:    NCT03476187
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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 : June 1, 2021
Sponsor:
Information provided by (Responsible Party):
Zoll Medical Corporation

Tracking Information
First Submitted Date  ICMJE February 19, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date June 1, 2021
Actual Study Start Date  ICMJE June 25, 2018
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
Correlation of µCor measured thoracic fluid index to heart failure related clinical events [ Time Frame: 3-6 months ]
Reading include: thoracic fluid index.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2018)
  • Correlation of cardiac rhythm µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: cardiac rhythm
  • Correlation of respiration rate µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: respiration rate
  • Correlation of posture µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: posture
  • Correlation of physical activity µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: physical activity
  • Correlation of hospitalizations µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: hospitalizations
  • Correlation of medication changes µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: medication changes
  • Correlation of symptom changes µCor measurements to heart failure related clinical events [ Time Frame: 3-6 months ]
    Readings include: symptom changes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Benefits of µCor in Ambulatory Decompensated Heart Failure
Official Title  ICMJE Benefits of µCor in Ambulatory Decompensated Heart Failure
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Heart Failure
Intervention  ICMJE Device: µCor
Monitor with µCor
Study Arms  ICMJE Experimental: µCor wearers
Wear the µCor device
Intervention: Device: µCor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 15, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mike A. Osz, B.Sc. (Hons) +1-412-968-3472 mosz@zoll.com
Contact: Tara Roberts tara.roberts@zoll.com
Listed Location Countries  ICMJE Austria,   Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03476187
Other Study ID Numbers  ICMJE 90D0182
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zoll Medical Corporation
Study Sponsor  ICMJE Zoll Medical Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven J. Szymkiewicz, MD Zoll Medical Corporation
PRS Account Zoll Medical Corporation
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP