Heart Failure Clinical Trial

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

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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.

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Full 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).

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Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

352

Study ID:

NCT05168787

Recruitment Status:

Enrolling by invitation

Sponsor:

Methodist Health System

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There is 1 Location for this study

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

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Study is for people with:

Heart Failure

Estimated Enrollment:

352

Study ID:

NCT05168787

Recruitment Status:

Enrolling by invitation

Sponsor:


Methodist Health System

How clear is this clinincal trial information?

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