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BMADHF: Benefits of µCor in Ambulatory Decompensated Heart Failure

Sponsor
Zoll Medical Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03476187
Collaborator
(none)
500
Enrollment
61
Locations
1
Arm
56.2
Anticipated Duration (Months)
8.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: µCor
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
N/A
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 :
Jun 25, 2018
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: µCor wearers

Wear the µCor device

Device: µCor
Monitor with µCor

Outcome Measures

Primary Outcome Measures

  1. Correlation of µCor measured thoracic fluid index to heart failure related clinical events [3-6 months]

    Reading include: thoracic fluid index.

Secondary Outcome Measures

  1. Correlation of cardiac rhythm µCor measurements to heart failure related clinical events [3-6 months]

    Readings include: cardiac rhythm

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

    Readings include: respiration rate

  3. Correlation of posture µCor measurements to heart failure related clinical events [3-6 months]

    Readings include: posture

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

    Readings include: physical activity

  5. Correlation of hospitalizations µCor measurements to heart failure related clinical events [3-6 months]

    Readings include: hospitalizations

  6. Correlation of medication changes µCor measurements to heart failure related clinical events [3-6 months]

    Readings include: medication changes

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

    Readings include: symptom changes

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mobile Heart Specialists, PC Mobile Alabama United States 36608
2 University Hospital Mobile Alabama United States 36617
3 NEA Baptist Clinic Jonesboro Arkansas United States 72405
4 Cardiovascular Innovation and Research Center, Inc. Long Beach California United States 90813
5 Los Alamitos Cardiovascular Los Alamitos California United States 90720
6 Nova Clinical Research LLC Bradenton Florida United States 34209
7 South Palm Cardiovascular Research Institute Delray Beach Florida United States 33446
8 Holy Cross Medical Group Fort Lauderdale Florida United States 33308
9 The Cardiac and Vascular Institute Research Foundation Gainesville Florida United States 32605
10 Baptist Heart Specialists Jacksonville Florida United States 32250
11 The Heart Institute at Largo Largo Florida United States 33770
12 Mount Sinai Medical Center Miami Beach Florida United States 33140
13 Cardiovascular Institute of Central Florida Ocala Florida United States 34471
14 Northside Hospital Saint Petersburg Florida United States 33709
15 University of South Florida Dept of Cardiovascular Sciences Tampa Florida United States 33609
16 Cardiology Practice Tampa Tampa Florida United States 33613
17 Cardiovascular Consultants of South Georgia Thomasville Georgia United States 31792
18 Fox Valley Clinical Research Center Aurora Illinois United States 60506
19 The Loretto Hospital Chicago Illinois United States 60644
20 Chicago Medical Research LLC Hazel Crest Illinois United States 60429
21 Loyola University Medical Center Maywood Illinois United States 60153
22 Unity Point Health Cardiovascular Services Peoria Illinois United States 61606
23 DuPage Medical Group Winfield Illinois United States 60190
24 Grace Research LLC Bossier City Louisiana United States 71111
25 Clinical Trials of America, LLC Monroe Louisiana United States 71201
26 Clinical Trials of America, LLC West Monroe Louisiana United States 71291
27 Massachusetts General Hospital Boston Massachusetts United States 02114
28 Cardiology Institute of Michigan Flint Michigan United States 48507
29 Hennepen Healthcare Research Institute Minneapolis Minnesota United States 55415
30 Nebraska Heart Institute Grand Island Nebraska United States 68803
31 Nebraska Heart Institute Lincoln Nebraska United States 68526
32 University Medical Center of Southern Nevada Las Vegas Nevada United States 89102
33 New Jersey Heart Linden New Jersey United States 07036
34 AtlantiCare Regional Medical Center Pomona New Jersey United States 08240
35 Trinity Medical WNY Buffalo New York United States 14215
36 SJH Cardiology Associates Liverpool New York United States 13088
37 University of Rochester Medical Center Rochester New York United States 14642
38 East Carolina Heart Institute Greenville North Carolina United States 27834
39 NC Heart & Vascular Research Raleigh North Carolina United States 27607
40 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157
41 OUHSC Oklahoma City Oklahoma United States 73104
42 UMPC Hamot Erie Pennsylvania United States 16550
43 Lancaster General Hospital Lancaster Pennsylvania United States 17602
44 The Guthrie Clinic Sayre Pennsylvania United States 18840
45 Cardiology Consultants of Philadelphia Yardley Pennsylvania United States 19067
46 Palmetto Health Advanced Heart Health Center Columbia South Carolina United States 29203
47 The Jackson Clinic, PA Jackson Tennessee United States 38301
48 PharmaTex Research Amarillo Texas United States 79106
49 JPS Health Network Fort Worth Texas United States 76104
50 Texas Cardiovascular Institute Fort Worth Texas United States 76104
51 Northwest Houston Cardiology Houston Texas United States 77070
52 CardioVogage McKinney Texas United States 75071
53 Texas Institute of Cardiology McKinney Texas United States 75071
54 Riverside Hospital Inc. Newport News Virginia United States 23601
55 Chippenham Hospital Richmond Virginia United States 23225
56 Henrico Doctors Hospital Richmond Virginia United States 23229
57 Marshall Cardiology Huntington West Virginia United States 25701
58 Universitätsklinik für Innere Medizin II, Abteilung für Kardiologie Vienna Austria
59 St. Vinzenz-Hospital; Akademisches Lehrkrankenhaus der Universität zu Köln, Innere Medizin III Cologne Germany
60 Herzzentrum Leipzig GmbH Leipzig Germany 04289
61 Klinikum rechts der Isar - Technische Universität München, Klinik und Poliklinik für Innere Medizin I Munich Germany

Sponsors and Collaborators

  • Zoll Medical Corporation

Investigators

  • Study Director: Steven J. Szymkiewicz, MD, Zoll Medical Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zoll Medical Corporation
ClinicalTrials.gov Identifier:
NCT03476187
Other Study ID Numbers:
  • 90D0182
First Posted:
Mar 23, 2018
Last Update Posted:
May 3, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Heart Failure

Study Results

No Results Posted as of May 3, 2022