Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize GDMT Using Wearable Sensors (AIM-POWER)
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|ClinicalTrials.gov Identifier: NCT04191330|
Recruitment Status : Recruiting
First Posted : December 9, 2019
Last Update Posted : March 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: BiovitalsHF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Artificial Intelligence Mobile Health Trial Of A Digital Platform To Optimize Guideline Directed Heart Failure Therapy Using Wearable Sensors|
|Actual Study Start Date :||January 27, 2020|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||October 2021|
No Intervention: Control
Subjects in the Control Arm will receive standard of care as normally provided in the clinical center where the study is being conducted.
Subjects randomized to the Intervention Arm will be remotely monitored for 90 days using the BiovitalsHF platform to manage initiation and titration of GDMT with and outside of normal or traditional clinical encounters.
BiovitalsHFTM is a cloud-based, Clinical Decision Support Platform that incorporates continuous physiology data from remote vital signs monitoring devices and electronic patient reported outcome (ePRO) monitoring of subjects at-home to support GDMT dose titration for HFrEF patients.
- Difference in percent of subjects at 50% target GDMT dose [ Time Frame: 90 days ]The primary endpoint will be the difference, at 90 days, between the intervention and control arm in the percentage of subjects on beta-blocker, ACEi/ARB/ or ARNI, and MRA at 50% target dose
- Difference in percent of subjects at target GDMT dose [ Time Frame: 90 days ]The key secondary endpoint will be the percentage of subjects on target dose of GDMT
- Change in NT-proBNP [ Time Frame: 90 and 365 days ]Change in NT-proBNP, from baseline, between the control and intervention arms at day 90 and 365.
- HF Hospitalizations [ Time Frame: 90 days ]The difference of HF Hospitalizations between the control and intervention arms
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): NCT04191330
|Contact: Trace Brookinsemail@example.com|
|United States, Alabama|
|Appalachian Cardiovascular Associates||Recruiting|
|Fort Payne, Alabama, United States, 35967|
|Contact: Sanjeev Saxena, MD 256-997-9200|
|Study Chair:||Akshay Desai, MD||Brigham and Womens Hospital|
|Principal Investigator:||Maulik Majmudar, MD||Biofourmis Inc.|