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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-520660-18-00
Acronym
AIFA-CARDIO-129
Enrollment
368
Registered
2025-11-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Brief summary

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.

Detailed description

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

Interventions

DRUGSPIRONOLACTONE
DRUGLOSARTAN
DRUGTRANDOLAPRIL
DRUGENALAPRIL
DRUGOLMESARTAN
DRUGIRBESARTAN
DRUGBISOPROLOL
DRUGSACUBITRIL VALSARTAN
DRUGNEBIVOLOL
DRUGRAMIPRIL
DRUGVALSARTAN
DRUGPERINDOPRIL
DRUGCANDESARTAN
DRUGCANRENONE
DRUGCARVEDILOL
DRUGFINERENONE
DRUGEMPAGLIFLOZIN
DRUGQUINAPRIL
DRUGMETOPROLOL
DRUGFOSINOPRIL
DRUGEPLERENONE
DRUGPOTASSIUM CANRENOATE
DRUGDAPAGLIFLOZIN
DRUGCAPTOPRIL
DRUGLISINOPRIL

Sponsors

Policlinico San Donato S.p.A.
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.—

Secondary

MeasureTime frame
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—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026