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.
Parallel
Guideline-Directed Medical Therapy (GDMT)
DrugGuideline-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.
Composite of all-cause mortality, heart failure (HF) readmission, or worsening HF within 1 year.
Composite endpoint including occurrence of (1) death from any cause, (2) hospital readmission for heart failure, or (3) clinically assessed worsening of heart failure.
Optimization of Beta-blocker Therapy
Percentage of participants achieving dose optimization of beta-blockers according to guideline-recommended targets or maximum tolerated dose.
Optimization of ACEi/ARB/ARNI Therapy
Proportion of participants achieving dose optimization of ACE inhibitors, angiotensin receptor blockers, or angiotensin receptor-neprilysin inhibitors according to guideline-recommended targets or maximum tolerated dose.
Optimization of Mineralocorticoid Receptor Antagonists (MRAs)
percentage of participants achieving dose optimization of MRAs at recommended dose or maximum tolerated dose.
Optimization of SGLT2 Inhibitors
Percentage of poulation achieving full implementation of SGLT2 inhibitors
Proportion of participants experiencing the composite endpoint of all-cause mortality, heart failure hospitalization, or worsening heart failure at 12 months
Proportion of participants experiencing at least one of the following events within 12 months: all-cause mortality, hospitalization for heart failure, or worsening heart failure. Worsening heart failure is defined as deterioration of heart failure signs and symptoms in a patient with chronic heart failure despite previously stable background therapy, requiring urgent escalation of therapy, including emergency department visit or outpatient intravenous diuretic therapy, with or without intensification of oral therapy. The composite endpoint is defined as the occurrence of any of the above events within 12 months. Results will be reported as the proportion of participants with ≥1 event in the following pre-specified subgroups: * Heart failure phenotype: HFrEF and HFmrEF versus HFpEF * Age: \<65 years versus ≥65 years * Patients with Diabetes mellitus * patients with Chronic kidney disease * patients with obesity
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IRCCS Policlinico S. Donato
Lead sponsor
Agenzia Italiana del Farmaco
Collaborator
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