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

Official Summary

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).

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 368 participants

Interventions

• DRUG: Guideline-Directed Medical Therapy (GDMT) — Guideline-directed medical therapy (GDMT) including beta-blockers, ACE inhibitors or ARBs or ARNIs, mineralocorticoid receptor antagonists, and SGLT2 inhibitors, all approved and commercially available, used according to current ESC guidelines. Participants in the high-intensity care arm are assigned to a strategy of rapid initiation and optimization of GDMT based on the STRONG-HF protocol. Eligible therapies (beta-blockers, ACEi/ARB/ARNI, mineralocorticoid receptor antagonists, and SGLT2 inhib

Primary Outcomes

• Composite of all-cause mortality, heart failure (HF) readmission, or worsening HF within 1 year. (12 months)

Secondary Outcomes

• Optimization of Beta-blocker Therapy (12 months)
• Optimization of ACEi/ARB/ARNI Therapy (12 months)
• Optimization of Mineralocorticoid Receptor Antagonists (MRAs) (12 months)
• Optimization of SGLT2 Inhibitors (12 months)
• Discontinuation of GDMT due to side effects (12 months)

Trial Locations

• IRCCS Policlinico San Donato, San Donato Milanese, MILANO, Italy
• Azienda Ospedaliero Universitaria Delle Marche, Ancona, Italy
• Azienda Sanitaria Locale Bari, Bari, Italy
• Azienda USL Toscana Nord Ovest - Cecina, Cecina, Italy
• Ospedale Universitario di Ferrara, Ferrara, Italy
• Azienda USL Toscana Centro, Florence, Italy
• Centro Cardiologico Monzino, Milan, Italy
• Istituto Auxologico Italiano, Milan, Italy
• Fondazione Toscana Gabriele Monasterio, Pisa, Italy
• Ospedale S. Maria delle Croci, Ravenna, Italy
• ...and 3 more locations

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