Pharmacological Optimization in Prevention in Heart Failure: A Sex-gap?

The goal of this clinical trial is to learn whether a rapid and intensive optimization of heart failure medications in women can improve outcomes after hospitalization for heart failure. It will also investigate the safety and the tolerance of these treatments when given at full guideline-recommended doses. The main questions it aims to answer are: 1. Does intensive medication optimization reduce death or hospital readmissions for heart failure within one year? 2. Do women benefit as much as men from intensive and full-dose heart failure therapy? 3. Is this treatment protocol safe and feasible also in women? Researchers will compare two groups of women hospitalized for heart failure: * High-intensity care: starting and increasing all recommended heart-failure medications as quickly as possible and monitoring patients closely during the first weeks after discharge. * Usual care: medications are started and adjusted gradually, according to the judgment of the treating cardiologist and the patient's usual care team. The study will follow participants for 12 months to see whether the high-intensity strategy reduces death, hospital readmission for heart failure, or worsening symptoms. It will also evaluate side effects, medication tolerance, and quality of life. Participants will be randomly assigned to one of the two groups, attend regular follow-up visits for one year, complete a short quality-of-life questionnaire (EQ-5D). This study will include about 360 women from 13 hospitals in Italy. It is sponsored by IRCCS Policlinico San Donato and funded by the Italian Medicines Agency (AIFA).

NCT Number	NCT07295522
Lead Sponsor	IRCCS Policlinico S. Donato Collaborators: Agenzia Italiana del Farmaco
Conditions	Heart Failure, Acute Heart Failure, Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure With Preserved Ejection Fraction (HFPEF), Heart Failure With Mildly Reduced Ejection Fraction
Enrollment	368 participants
Start Date	2026-04-08
Primary Completion	2027-06-08 (estimated)
Study Completion	2028-06-08 (estimated)
Updated on ClinicalTrials.gov	2026-03-30