Prospective Monitoring of Angiotensin Receptor Neprilysin Inhibitor in Older Adults With Heart Failure and Frailty

NCT04743063 | Unknown FDA Drug

• 1 other identifier: 2019P000110-ARNI
• Study Type: observational
• Target: 40,000
• Locations: 1 country
• Sites: 1

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) 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.

Conditions

Heart Failure, Systolic; Frailty

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (6)

• 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

Study Arms (2)

New users of angiotensin receptor neprilysin inhibitor

Drug: sacubitril/valsartan

New users of angiotensin II receptor blockers

Drug: Angiotensin II Receptor Blockers

Interventions

sacubitril/valsartan DRUG

Initiation of sacubitril/valsartan, identified using prescription fill in pharmacy claims

New users of angiotensin receptor neprilysin inhibitor

Angiotensin II Receptor Blockers DRUG

Initiation of ARBs, identified using prescription fill in pharmacy claims

Also known as: azilsartan, candesartan, eprosartan, Irbesartan, losartan, Olmesartan, telmisartan, valsartan

New users of angiotensin II receptor blockers

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

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
• Note: If a patient meets the above-mentioned eligibility criteria more than once, only the first record will be included.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham And Women's Hospital

Boston, Massachusetts, 02120, United States

Location

MeSH Terms

Conditions

Heart Failure, Systolic; Frailty

Interventions

sacubitril and valsartan sodium hydrate drug combination; Angiotensin Receptor Antagonists; azilsartan; candesartan; eprosartan; Irbesartan; Losartan; olmesartan; Telmisartan; Valsartan

Condition Hierarchy (Ancestors)

Heart Failure; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Spiro Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Imidazoles; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Dae Hyun Kim, MD, MPH, ScD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 3, 2021
• First Posted: February 8, 2021
• Study Start: January 14, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)