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).
Female patients >18 <85 years.
Hospital admission within the 72 hours prior to Screening for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation.
All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm.
All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L).
Male patients
Age < 18 or > 85 years.
Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening.
Significant pulmonary disease contributing substantially to the patients' dyspnoea such as FEV1 <1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as primary pulmonary hypertension or recurrent pulmonary embolism.
IRCCS Policlinico S. Donato
Lead sponsor
Agenzia Italiana del Farmaco
Collaborator