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OpenTrials
Completed

NCT Number: NCT05168787

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Methodist Dallas Medical Center Pharmacy

Dallas, Texas, 75203, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sacubitril/valsartan

Drug

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.

Primary outcomes

  1. Composite CV mortality or HF hospitalization

    Time frame: April 2017 to August 2020

    Composite CV mortality or HF hospitalization

Secondary outcomes

  1. CV mortality

    Time frame: April 2017 to August 2020

    Individual components

  2. HF hospitalization

    Time frame: April 2017 to August 2020

    Individual components

  3. All-cause mortality

    Time frame: April 2017 to August 2020

    Individual components

  4. New atrial fibrillation

    Time frame: April 2017 to August 2020

    Individual components

  5. Renal function decline

    Time frame: April 2017 to August 2020

    Individual components

  6. Change in EF

    Time frame: April 2017 to August 2020

    Individual components

  7. Change in NYHA classification

    Time frame: April 2017 to August 2020

    Individual components

Sponsors and collaborators

Lead sponsor

Methodist Health System

Other

Registry information

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Dec 23, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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