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

Completed

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT07376265

Run by

Novartis Pharmaceuticals

People needed

1249

Starts

2023-10-20

Expected to finish

2024-04-11

Last updated by the study team

2026-02-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Novartis — East Hanover, New Jersey, United States

Full record on ClinicalTrials.gov

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