Efficacy and Safety of Sacubitril/Valsartan in African Am... | NCT05168787

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

NCT05168787

Sponsor

Methodist Health System

Status

Completed

Last Update Posted

Mar 27, 2026Actual

Enrollment

6,558Actual

Phase

Not provided

Conditions

Heart Failure

Interventions

sacubitril/valsartan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 13, 2020Actual

Primary Completion Date

Jul 8, 2025Actual

Completion Date

Jul 8, 2025Actual

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Dec 9, 2021

First Posted Date

Dec 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2026

Last Update Posted Date

Mar 27, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,558Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
CV mortality	Individual components	April 2017 to August 2020
HF hospitalization	Individual components	April 2017 to August 2020

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

AAs with HFrEF on sacubitril/valsartan therapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Crystal Brown, PharmD	Methodist Dallas Medical Center Pharmacy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Methodist Dallas Medical Center Pharmacy		Dallas	Texas	75203	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C549068	sacubitril and valsartan sodium hydrate drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided