Status:
UNKNOWN
Prospective Monitoring of Angiotensin Receptor Neprilysin Inhibitor in Older Adults With Heart Failure and Frailty
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Heart Failure, Systolic
Frailty
Eligibility:
All Genders
65+ years
Brief Summary
The objective of this study is to establish a near-real-time prospective monitoring program in Medicare, Optum and MarketScan Research data to evaluate the benefit of new cardiovascular disease (CVD) ...
Detailed Description
Data sources of use for this study are: Medicare Database, Optum Database, and MarketScan Research Database. All data from years 2014-2020 will be included in the study. This study follows a sequenti...
Eligibility Criteria
Inclusion
- Continuous enrollment for medical and drug insurance (e.g., Medicare Part A, B, and D) in \[-365, 0\] days
- Diagnosis of Heart Failure either two outpatient diagnosis or one inpatient diagnosis in \[-365, 0\] days
- Reduced Ejection Fraction \< 45% identified using a validated claims-based algorithm in \[-365, 0\] days
- Day 0 is the initiation date of the study drug.
Exclusion
- No prior use of Angiotensin receptor neprilysin inhibitor or angiotensin II receptor blocker in \[-365, -1\] days
- No recent HF hospitalization, defined as HF diagnosis (defined in attached protocol) in the primary position in the inpatient dataset in \[-60, 0\] days
- No recent nursing facility stay (defined in attached protocol) for \[-60, 0\] days
- Age \< 65 years
- Exposure to both drugs on day 0
- Contraindication to either drug (exclusion assessment window: \[-60, 0\] days, unless specified otherwise; algorithms specified in attached protocol)
- Note: If a patient meets the above-mentioned eligibility criteria more than once, only the first record will be included.
Key Trial Info
Start Date :
January 14 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
40000 Patients enrolled
Trial Details
Trial ID
NCT04743063
Start Date
January 14 2021
End Date
December 31 2022
Last Update
February 15 2021
Active Locations (1)
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1
Brigham And Women's Hospital
Boston, Massachusetts, United States, 02120