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

Novartis

Status

Completed

Conditions

Heart Failure

Study type

Observational

Funder types

Industry

Identifiers

NCT07376265

CLCZ696BPT07

Details and patient eligibility

About

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).

Enrollment

1,249 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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