MedTrace Logo

Initiation of ARNi and SGLT2i in Patients With HFrEF

NCT05989503 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2025-11-19

No results posted yet for this study

Summary

Heart failure (HF) is a condition in which the heart does not contract ("pump") or relax well, leading to insufficient perfusion of vital organs. Ankle swelling, fatigue, and breathlessness are some of the features of this syndrome. There are different causes for HF (e.g., infarct and hypertension) and two distinct types: HFpEF - HF with preserved ejection fraction - the heart "pumps" but does not relax well and HFrEF/HFmrEF - HF with reduced or mildly reduced ejection fraction - where the heart does not "pump" properly, here referred to as having HFrEF.

Patients with HFrEF experience substantially shorter life expectancies compared with people in the general population of similar age. Compared to the different available therapeutics for HFrEF patients, angiotensin receptor-neprilysin inhibitor (ARNi), sacubitril/valsartan, has shown superiority for improving clinical outcomes. Furthermore, the new recently drug sodium-glucose cotransporter 2 inhibitor (SGLT2i) was proven to reduce mortality and morbidity on top of well-adapted background therapy.

This work aims to test the safety of ARNi and SGLT2i initiation by comparing a strategy of simultaneous initiation of ARNi and SGLT2i versus sequential initiation of a SGLT2i first followed by an ARNi.

Conditions

  • Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

Sacubitril-valsartan

Sacubitril-valsartan titration at the discretion of the treating physician

DRUG

SGLT2 inhibitor

Either empagliflozin or dapagliflozin 10 mg/day

Sponsors & Collaborators

  • Unidade de Investigação e Desenvolvimento Cardiovascular (UnIC)

    collaborator UNKNOWN

  • Rede de Investigação em Saúde

    collaborator OTHER

  • Universidade do Porto

    lead OTHER

Principal Investigators

  • João P. Ferreira, MD, PhD · Universidade do Porto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-04
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Portugal

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05989503 on ClinicalTrials.gov