Initiation of ARNi and SGLT2i in Patients With HFrEF
Status:
Recruiting
Trial end date:
2025-02-01
Target enrollment:
Participant gender:
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.
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.
Phase:
Phase 4
Details
Lead Sponsor:
Universidade do Porto
Collaborators:
Rede de Investigação em Saúde Unidade de Investigação e Desenvolvimento Cardiovascular (UnIC)
Treatments:
Sacubitril and valsartan sodium hydrate drug combination Sodium-Glucose Transporter 2 Inhibitors Valsartan