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NCT07376265Completed

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

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

Source: ClinicalTrials.gov · Last updated 4 Feb 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
1249 (actual)
First submitted
22 Jan 2026
Start date
20 Oct 2023
Primary completion date
11 Apr 2024
Lead sponsor
Novartis Pharmaceuticals
NCT number
NCT07376265

What you commit to

  • Study type: Observational
  • Participants enrolled: 1249
  • From 20 Oct 2023 to the primary completion date, 11 Apr 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • History of angioedema or unacceptable side effects during receipt of SAC/VAL, ACEi or ARB
  • Severe hepatic impairment, biliary cirrhosis, and cholestasis

Lab values

  • Estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m\^2 at SAC/VAL, ACEi or ARB initiation

Other

  • Missing sex or date of birth
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Novartis
Coordinator of this site? Confirm its status
East HanoverUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.