NCT05168787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,558

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2020

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.9 years

First QC Date

December 9, 2021

Last Update Submit

March 24, 2026

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Composite CV mortality or HF hospitalization

    Composite CV mortality or HF hospitalization

    April 2017 to August 2020

Secondary Outcomes (7)

  • CV mortality

    April 2017 to August 2020

  • HF hospitalization

    April 2017 to August 2020

  • All-cause mortality

    April 2017 to August 2020

  • New atrial fibrillation

    April 2017 to August 2020

  • Renal function decline

    April 2017 to August 2020

  • +2 more secondary outcomes

Interventions

sacubitril/valsartanDRUG

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.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

AAs with HFrEF on sacubitril/valsartan therapy

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist Dallas Medical Center Pharmacy

Dallas, Texas, 75203, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Crystal Brown, PharmD

    Methodist Dallas Medical Center Pharmacy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2021

First Posted

December 23, 2021

Study Start

August 13, 2020

Primary Completion

July 8, 2025

Study Completion

July 8, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)