Initiation of ARNi and SGLT2i in Patients With HFrEF - Trial NCT05989503
Access comprehensive clinical trial information for NCT05989503 through Pure Global AI's free database. This Phase 4 trial is sponsored by Universidade do Porto and is currently Recruiting. The study focuses on Heart Failure With Reduced Ejection Fraction. Target enrollment is 172 participants.
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Study Focus
Sponsor & Location
Universidade do Porto
Timeline & Enrollment
Phase 4
Aug 04, 2023
Feb 01, 2025
Primary Outcome
Composite outcome (time-to-first event' occurrence during the 6 months of follow-up):
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.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT05989503
Non-Device Trial

