Not Yet RecruitingPhase 4

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

Italy368 participantsStarted 2026-04-08

Plain-language 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).

Who can participate

Age range18 Years – 85 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. Biomarker criteria for persistent congestion:
✓.1. At Screening, NT-proBNP \>1,800 pg/mL (2,350 pg/mL in case of atrial fibrillation) 5.2. At the time of Randomization (1-2 days prior to discharge), NT-proBNP \>1,000 pg/mL (1,300 pg/mL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode).
✓. At 1 week prior to admission, at Screening, and at Visit 2 6.1. If EF\<50% (ie HFrEF or HFmrEF) either \<½ the optimal dose of ACEi/ARB/ARNi and MRA and BB or no SGLT2i (see Table) must have been prescribed 6.2. If EF\>50% (ie HFpEF): \<½ the optimal dose of MRA (see Table) or no SGLT2i.
✓. Written informed consent to participate in the study.

What they're measuring

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

Timeframe: 12 months

Trial details

NCT IDNCT07295522

SponsorIRCCS Policlinico S. Donato

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-08

Contact for this trial

Massimo Piepoli, MD

0252774966 MASSIMO.PIEPOLI@GRUPPOSANDONATO.IT

View on ClinicalTrials.gov More Heart Failure trials

Plain-language summary

Who can participate

Age range18 Years – 85 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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).
✓. Biomarker criteria for persistent congestion:
✓.1. At Screening, NT-proBNP \>1,800 pg/mL (2,350 pg/mL in case of atrial fibrillation) 5.2. At the time of Randomization (1-2 days prior to discharge), NT-proBNP \>1,000 pg/mL (1,300 pg/mL in case of Atrial Fibrillation) to ensure the persistence of congestion and the acuity of the index episode).
✓. At 1 week prior to admission, at Screening, and at Visit 2 6.1. If EF\<50% (ie HFrEF or HFmrEF) either \<½ the optimal dose of ACEi/ARB/ARNi and MRA and BB or no SGLT2i (see Table) must have been prescribed 6.2. If EF\>50% (ie HFpEF): \<½ the optimal dose of MRA (see Table) or no SGLT2i.
✓. Written informed consent to participate in the study.

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

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

Plain-language summary

Who can participate

Inclusion criteria

What they're measuring

Trial details

Contact for this trial

Exclusion criteria