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Clinical Trials in the EU / 2025-520660-18-00
Completed Phase IV

Pharmacological optimization in prevention in Heart Failure: A Sex-gap? (PopS-HF Trial)

2025-520660-18-00 · tracked via the Priya Life Science EU tracker
Sponsor
Policlinico San Donato S.p.A.
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Cardiovascular Diseases
Decision date
17/11/2025
Enrollment target
368
Sites
Italy

Condition studied

Heart Failure

Investigational medicinal product(s)

LOSARTANLOSARTANDAPAGLIFLOZINCAPTOPRILLISINOPRILCANRENONEPERINDOPRILEMPAGLIFLOZINSACUBITRIL VALSARTANSACUBITRIL VALSARTANPERINDOPRILSPIRONOLACTONEFINERENONETRANDOLAPRILENALAPRILDAPAGLIFLOZINOLMESARTANBISOPROLOLLOSARTANCARVEDILOLCANRENONENEBIVOLOLQUINAPRILFINERENONEQUINAPRILCAPTOPRILBISOPROLOLRAMIPRILIRBESARTANMETOPROLOLVALSARTANEPLERENONEFOSINOPRILLISINOPRILVALSARTANOLMESARTANMETOPROLOLENALAPRILPOTASSIUM CANRENOATEEPLERENONERAMIPRILCANDESARTANFOSINOPRILEMPAGLIFLOZINCARVEDILOLSPIRONOLACTONETRANDOLAPRILPOTASSIUM CANRENOATELOSARTANNEBIVOLOLCANDESARTANIRBESARTAN

Eligibility

Age group
65+ years, 18-64 years
Sex
Female

Primary endpoint

Retrospective study: an up-to-date description of the “status quo” of the prescription of GDMT nationally and related inequality regarding sex in patients with HF based on analyses of National Registry data and Mecki Data-base. Prospective study: • all-cause mortality within 1 year or HF readmission or worsening HF.

Endpoint detail

Prospective study: a.the percentage of optimization of each single medical therapy (BB; ACEi, ARB or ARNi;and MRAs and SGLT2i)in women admitted with heart failure, b.effect of such intervention at 1 year:mortality;HF re-admission;worsening HF;quality of life (EQ-5D questionnaire). c.Other endpoints:include changes in biomarkers and changes in the primary and secondary endpoints in pre-determined subgroups including <50vs>50 EF;>vs<65 yr old,presence of diabetes,chronic kidney disease or obesity

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-520660-18-00 on CTIS ↗ ← All trials in the EU