Pure Global

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.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

Free Database
Powered by Pure Global AI
840K+ Trials
NCT05989503
Phase 4
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05989503
View on ClinicalTrials.gov
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Initiation of ARNi and SGLT2i in Patients With HFrEF
Initiation of Angiotensin Receptor-neprilysin Inhibitor (ARNi) and Sodium-glucose Cotransporter-2 Inhibitors (SGLT2i) in Patients With Heart Failure With Reduced Ejection Fraction (HFrEF): the INITIATE-HFrEF Randomized Open-label Trial

Study Focus

Sacubitril-valsartan

Interventional

drug

Sponsor & Location

Universidade do Porto

Porto,Porto,Porto,Porto,Porto, Portugal

Timeline & Enrollment

Phase 4

Aug 04, 2023

Feb 01, 2025

172 participants

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

Heart failure
Congestive heart failure
Heart failure, unspecified
Hypertensive heart disease with (congestive) heart failure
Left ventricular failure

Data Source

ClinicalTrials.gov

NCT05989503

Non-Device Trial