NCT04743063|UnknownFDA Drug
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Sponsor study identifier
observational
40,000
1 country
1
Study Start
January 14, 2021
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 14, 2021
Actual (reported)February 3, 2021
Actual (reported)February 8, 2021
Actual (reported)December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Number of patients with composite events of death or heart failure hospitalization
All-cause mortality OR heart failure hospitalization
July 2015 - December 2020
Number of patients with composite serious adverse events
Hypotension OR acute kidney injury/acute kidney failure OR hyperkalemia OR angioedema
July 2015 - December 2020
Number of patients with all-cause mortality
July 2015 - December 2020
Number of patients with heart failure hospitalization
July 2015 - December 2020
Number of patients with hypotension
July 2015 - December 2020
Number of patients with hyperkalemia
July 2015 - December 2020
Number of patients with acute kidney injury/acute kidney failure
July 2015 - December 2020
Initiation of sacubitril/valsartan, identified using prescription fill in pharmacy claims
Initiation of ARBs, identified using prescription fill in pharmacy claims
Study population includes older patients with heart failure with reduced ejection fraction who initiates an angiotensin receptor neprilysin inhibitor or an angiotensin II receptor blocker.
Brigham And Women's Hospital
Boston, Massachusetts, 02120, United States
Dae Hyun Kim, MD, MPH, ScD
Brigham and Women's Hospital
First Submitted
February 3, 2021
First Posted
February 8, 2021
Study Start
January 14, 2021
Actual (reported)Primary Completion
December 31, 2022
Estimated (date passed)Multimodal, Task-Aware Movement Assessment and Control: Clinic to the Home
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 15, 2021
Record last verified: 2021-02
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Source: ClinicalTrials.gov.
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