NCT07376265

Brief Summary

This was a retrospective, observational, comparative cohort study using secondary data from electronic health records (EHR) from a local health unit that provides primary, secondary and tertiary care to a resident population in northern Portugal. The study aimed to assess the comparative effectiveness of sacubitril/valsartan (SAC/VAL) versus angiotensin-converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (ARB) in patients with heart failure with reduced ejection fraction (HFrEF).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,249

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 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

October 20, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2024

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 22, 2026

Last Update Submit

February 2, 2026

Conditions

Heart Failure

Keywords

Sacubritril-valsartanHeart failureCardiovascular outcomes

Outcome Measures

Primary Outcomes (1)

  • Hazard Ratio for the Composite of Cardiovascular Death or Heart Failure Hospitalization

    180 days, 810 days, 1260 days

Secondary Outcomes (20)

  • Hazard Ratio for Death From Cardiovascular Causes

    180 days, 810 days, 1260 days

  • Hazard Ratio for Hospitalization for Heart Failure

    180 days, 810 days, 1260 days

  • Hazard Ratio for First Hospitalization or Emergency Room Visit

    180 days, 810 days, 1260 days

  • Hazard Ratio for First Cardiovascular-specific Hospitalization

    180 days, 810 days, 1260 days

  • Hazard Ratio for the Composite of Death From Cardiovascular Causes, Hospitalization for Heart Failure, Non-fatal Myocardial Infarction and Non-fatal Stroke

    180 days, 810 days, 1260 days

  • +15 more secondary outcomes

Study Arms (3)

SAC/VAL Cohort

Adult patients with HFrEF undergoing therapy with SAC/VAL.

ACEi/ARB Cohort

Adult patients with HFrEF undergoing therapy with ACEi/ARB.

Missed Opportunities Cohort

Patients who were eligible for but did not receive SAC/VAL.

Eligibility Criteria

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

The study included heart failure patients with reduced ejection fraction.

You may qualify if:

  • Left ventricular ejection fraction (LVEF) \< 40%
  • Brain natriuretic peptide (BNP) ≥35 pg/mL or N-terminal prohormone of brain natriuretic peptide (NT-proBNP) ≥125 pg/mL
  • Had a record in the database in the 365 days prior to the index date

You may not qualify if:

  • Missing sex or date of birth
  • Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 at SAC/VAL, ACEi or ARB initiation
  • History of angioedema or unacceptable side effects during receipt of SAC/VAL, ACEi or ARB
  • Severe hepatic impairment, biliary cirrhosis, and cholestasis
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

East Hanover, New Jersey, 07936, United States

Location

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

October 20, 2023

Primary Completion

April 11, 2024

Study Completion

April 11, 2024

Last Updated

February 4, 2026

Record last verified: 2026-01

Locations

US(1)