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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05168787
• Other study ID #: 047.PHA.2020.A
• Status: Enrolling by invitation
• Start date: August 13, 2020
• Est. completion date: August 2024

Study information

• Verified date: February 2024
• Source: Methodist Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 352
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• sacubitril/valsartan
Sacubitril belongs to a class of drugs called neprilysin inhibitors and valsartan belongs to a class of drugs called angiotensin receptor blockers (ARBs). They work by relaxing blood vessels so that blood can flow more easily, which makes it easier for your heart to pump blood to your body.

Locations

Country	Name	City	State
United States	Methodist Dallas Medical Center Pharmacy	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite CV mortality or HF hospitalization	Composite CV mortality or HF hospitalization	April 2017 to August 2020
Secondary	CV mortality	Individual components	April 2017 to August 2020
Secondary	HF hospitalization	Individual components	April 2017 to August 2020
Secondary	All-cause mortality	Individual components	April 2017 to August 2020
Secondary	New atrial fibrillation	Individual components	April 2017 to August 2020
Secondary	Renal function decline	Individual components	April 2017 to August 2020
Secondary	Change in EF	Individual components	April 2017 to August 2020
Secondary	Change in NYHA classification	Individual components	April 2017 to August 2020