Prospective Monitoring of Angiotensin Receptor Neprilysin Inhibitor in Older Adults With Heart Failure and Frailty
Status unconfirmed
Conditions studied: Heart Failure, Systolic, Frailty
In brief
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) drugs for older adults with frailty. Prospective monitoring program seeks to find early effectiveness and safety signals of new drugs by updating the analysis at regular intervals as new Medicare data become available. This study specifically aims to emulate a prospective surveillance of the effectiveness and safety of Angiotensin Receptor Neprilysin Inhibitor(ARNI) vs. a comparator, Angiotensin II Receptor Blockers (ARBs), in older adults with Heart Failure with Reduced Ejection Fraction (HFrEF) and different frailty status. This program will be enhanced by incorporating a novel claims-based frailty index, which has been shown useful in assessing how the benefits and harms of drug therapy vary by frailty.
Key facts
- Study ID
- NCT04743063
- Run by
- Brigham and Women's Hospital
- People needed
- 40000
- Starts
- 2021-01-14
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2021-02-15
Who can join
Age: 65 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Brigham And Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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