Efficacy and Safety of Sacubitril/Valsartan in African American Patients With Heart Failure With Reduced Ejection Fraction

There is limited long-term evidence specific to AAs with HFrEF on sacubitril/valsartan therapy. Plasma NT-proBNP levels are lower in AA individuals as compared to Caucasian individuals in general. However, the mechanism of action of sacubitril specifically targets the activity of BNP. Therefore, there is the potential that the mechanism of action of sacubitril/valsartan may be less effective in AAs.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Drug: sacubitril/valsartan

Detailed Description

To assess the efficacy and safety of sacubitril/valsartan in AA patients with HFrEF by comparing the outcomes of AA patients on ARNI therapy plus SOC (with or without hydralazine/isosorbide [H-IDSN]) to AA patients receiving ACEi/ARB therapy plus SOC (with or without H-ISDN).

• Study Type: Observational
• Enrollment (Actual): 6558

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center Pharmacy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

AAs with HFrEF on sacubitril/valsartan therapy

Description

Inclusion Criteria:

• Self-identified as AA
• NYHA class II-IV symptoms
• Left ventricle EF <40%
• Receiving stable doses of standard therapy, including ACE inhibitors or ARBs, ARNI (within a month from discharge), combination H-ISDN, beta blockers, digoxin, spironolactone, and diuretics as tolerated.
• Patient must have minimum of three months follow-up

Exclusion Criteria:

• Patients not meeting inclusion criteria

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite CV mortality or HF hospitalization	Composite CV mortality or HF hospitalization	April 2017 to August 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CV mortality	Individual components	April 2017 to August 2020
HF hospitalization	Individual components	April 2017 to August 2020
All-cause mortality	Individual components	April 2017 to August 2020
New atrial fibrillation	Individual components	April 2017 to August 2020
Renal function decline	Individual components	April 2017 to August 2020
Change in EF	Individual components	April 2017 to August 2020
Change in NYHA classification	Individual components	April 2017 to August 2020

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Crystal Brown, PharmD, Methodist Dallas Medical Center Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2020
• Primary Completion (Actual): July 8, 2025
• Study Completion (Actual): July 8, 2025

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; sacubitril and valsartan sodium hydrate drug combination
• Other Study ID Numbers: 047.PHA.2020.A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No