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

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).

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

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.

Sponsors & Collaborators

• Agenzia Italiana del Farmaco

  collaborator OTHER_GOV

• IRCCS Policlinico S. Donato

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-08

Primary Completion

2027-06-08

Completion

2028-06-08

Countries

• Italy

Study Locations