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 : May 19, 2020
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: µCor||Not Applicable|
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)|
|Official Title:||Benefits of µCor in Ambulatory Decompensated Heart Failure|
|Actual Study Start Date :||June 25, 2018|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2022|
Experimental: µCor wearers
Wear the µCor device
Monitor with µCor
- Correlation of µCor measured thoracic fluid index to heart failure related clinical events [ Time Frame: 3-6 months ]Reading include: thoracic fluid index.
- 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
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
|Contact: Mike A. Osz, B.Sc. (Hons)||+email@example.com|
|Contact: Tara Robertsfirstname.lastname@example.org|
|Study Director:||Steven J. Szymkiewicz, MD||Zoll Medical Corporation|