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Completed

NCT Number: NCT07376265

A Real-world Study to Compare the Effectiveness of Sacubitril/Valsartan Versus ACEi/ARB in HFrEF Patients

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).

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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

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 180 days, 810 days, 1260 days

Secondary outcomes

  1. Hazard Ratio for Death From Cardiovascular Causes

    Time frame: 180 days, 810 days, 1260 days

  2. Hazard Ratio for Hospitalization for Heart Failure

    Time frame: 180 days, 810 days, 1260 days

  3. Hazard Ratio for First Hospitalization or Emergency Room Visit

    Time frame: 180 days, 810 days, 1260 days

    Hospitalizations or emergency room visits for heart failure, and any cause were recorded.

  4. Hazard Ratio for First Cardiovascular-specific Hospitalization

    Time frame: 180 days, 810 days, 1260 days

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

    Time frame: 180 days, 810 days, 1260 days

  6. Hazard Ratio for Implantable Cardioverter-defibrillator (ICD) Procedure

    Time frame: 180 days, 810 days, 1260 days

  7. Hazard Ratio for All-cause Mortality

    Time frame: 180 days, 810 days, 1260 days

  8. Hazard Ratio for Improved LVEF

    Time frame: 180 days, 810 days, 1260 days

    Improved LVEF was defined as having at least one LVEF measurement equal or above 40% after having an LVEF under 40%.

  9. Pearson Correlation Coefficient Between Change From Baseline in NT-proBNP and LVEF

    Time frame: 180 days, 810 days, 1260 days

  10. Change From Baseline in NT-proBNP

    Time frame: 180 days, 810 days, 1260 days

  11. Change From Baseline in LVEF

    Time frame: 180 days, 810 days, 1260 days

  12. Total Healthcare Resource Utilization Costs per Calendar Year

    Time frame: Up to 5 years

    Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams.

  13. Number of Days Patients Were Absent From Work per Calendar Year

    Time frame: Up to 5 years

  14. Healthcare Resource Utilization Costs per Patient per Year

    Time frame: Up to 5 years

    Healthcare utilization costs included costs for inpatient care, outpatient care, medication, and exams.

  15. Hazard Ratio for Hyperkalemia

    Time frame: 180 days, 810 days, 1260 days

  16. Rate of Dose Titration Events per 100-Person-Years

    Time frame: 180 days, 810 days, 1260 days

    Rates were measured for dose titrations from:

    • low to medium
    • medium to low
    • medium to high
    • high to medium

  17. Rate of Patients Reaching the Maximum Dose per 100-Person-Years

    Time frame: 180 days, 810 days, 1260 days

  18. Rate of Treatment Discontinuation

    Time frame: 180 days, 810 days, 1260 days

  19. Number of Patients by Demographic Category

    Time frame: Baseline

    Demographics included age and sex.

  20. Number of Patients by Clinical Characteristic Category

    Time frame: Baseline

    Clinical characteristics included:

    • New York Heart Association (NYHA) Class
    • eGFR ≥ 60 mL/minute/1.73 m^2
    • eGFR < 60 mL/minute/1.73 m^2
    • LVEF ≤ 35%
    • LVEF > 35%
    • Type of medication
    • Comorbidities

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Comparative Effectiveness of Sacubitril/Valsartan vs ACEi/ARB in HFrEF Patients: Real Heart PT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2026
Registry last updated
Feb 4, 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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