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

• Conditions: Heart Failure

• Registration Number: NCT05168787
• Lead Sponsor: Methodist Health System

Brief Summary

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.

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 Timeline

• Study Start: 2020-08-13
• Study First Submitted: 2021-12-09
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-23
• Status Verified: 2024-02
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 352

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite CV mortality or HF hospitalization	April 2017 to August 2020	Composite CV mortality or HF hospitalization

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Methodist Dallas Medical Center Pharmacy; 🇺🇸 Dallas, Texas, United States