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NOT YET RECRUITING
NCT07295522
PHASE4

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

Sponsor: IRCCS Policlinico S. Donato

View on ClinicalTrials.gov

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).

Key Details

Gender

FEMALE

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

368

Start Date

2026-04-08

Completion Date

2028-06-08

Last Updated

2026-03-30

Healthy Volunteers

No

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 inhibitors for HFrEF/HFmrEF; MRA and SGLT2 inhibitors for HFpEF) are started during hospitalization at least at half of the recommended target dose, followed by frequent clinical assessments and dose titration, when clinically appropriate, within 6 weeks. Safety monitoring includes clinical examination, vital signs, laboratory tests (NT-proBNP, electrolytes, kidney function), and additional visits after each titration if needed.

Locations (13)

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

Azienda USL IRCCS Di Reggio Emilia

Reggio Emilia, Italy

Fondazione Policlinico Universitario Campus Bio-medico

Roma, Italy

Ospedale San Camillo Forlanini

Roma, Italy