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Can quick drug optimization after heart failure hospitalization save lives in women?

NCT ID NCT07295522

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether quickly starting and increasing guideline-recommended heart failure medications after hospitalization improves outcomes in women. About 360 women from 13 Italian hospitals will be randomly assigned to either a high-intensity care group (rapid drug optimization) or usual care. Researchers will track deaths, hospital readmissions, and worsening heart failure over one year to see if the intensive approach is safer and more effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Guideline-directed medical therapy (GDMT) including beta-blockers, ACE inhibitors, ARBs, ARNIs, mineralocorticoid receptor antagonists, and SGLT2 inhibitors
What this could lead to
If successful, this could show that a rapid, intensive medication strategy after heart failure hospitalization reduces deaths and readmissions, especially for women.
What could go wrong
This is a Phase 4 study with a moderate sample size, so results may not apply to all heart failure patients. The intensive drug regimen may cause side effects or be poorly tolerated in some women.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 368 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Female patients \>18 \<85 years. 2. 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. 3. All measures within 24 hours prior to Randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm. 4. All measures within 24 hours prior to Randomization of serum potassium ≤ 5.0 mEq/L (mmol/L). 5. Biomarker criteria for persistent congestion: 5.1. 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). 6. 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. 7. Written informed consent to participate in the study. Exclusion Criteria: 1. Male patients 2. Age \< 18 or \> 85 years. 3. Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening. 4. 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. 5. Myocardial infarction, unstable angina or cardiac surgery within 3 months, or cardiac resynchronization therapy (CRT) device implantation within 3 months, or percutaneous transluminal coronary intervention (PTCI), within 1 month prior to Screening or during the index event. 6. Index Event (admission for Acute Heart Failure) triggered primarily by a correctable aetiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response \>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \<45 beats per minute), infection, severe anaemia, acute coronary syndrome, pulmonary embolism, exacerbation of Chronic Obstructive Pulmonary Disease (COPD), planned admission for device implantation or severe non-adherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not an exclusion. 7. Uncorrected thyroid disease, active myocarditis, or known amyloid or hypertrophic obstructive cardiomyopathy. 8. History of heart transplant or on a transplant list or using or planned to be implanted with a ventricular assist device. 9. Sustained ventricular arrhythmia with syncopal episodes within the 3 months prior to screening that is untreated. 10. Presence at Screening of any hemodynamically significant valvular stenosis or regurgitation, except mitral or tricuspid regurgitation secondary to left ventricular dilatation, or the presence of any hemodynamically significant obstructive lesion 11. Active infection at any time during the AHF hospitalization prior to Randomization based on abnormal temperature and elevated WBC or need for intravenous antibiotics. 12. Stroke or Transient Ischemic Attack (TIA) within the 3 months prior to Screening. 13. Primary liver disease considered to be life threatening. 14. Renal disease or eGFR \< 30 mL/min/1.73m2 (as estimated by the simplified MDRD formula) at Screening or history of dialysis. 15. Psychiatric or neurological disorder, cirrhosis, or active malignancy leading to a life expectancy \< 6 months. 16. Prior (defined as less than 30 days from screening) or current enrollment in a CHF trial or participation in an investigational drug or device study within the 30 days prior to screening or 5 half-lives of the study drug, whichever is longer. 17. Discharge for the AHF hospitalization anticipated to be \>14 days from admission, or to a long-term care facility. Randomization must occur within 12 days following admission and at 1-2 days prior to anticipated discharge. 18. Inability to comply with all study requirements, due to major co-morbidities, social or financial issues or a history of noncompliance with medical regimens, that might compromise the patient's ability to understand and/or comply with the protocol instructions or follow-up procedures. 19. Pregnant or nursing (lactating) women. 20. Hypersensitivity to the active substance or to any of the excipients as indicated in Summary of Product Characteristics of Investigational Medicinal Product (IMPs). 21. Angioedema. 22. Severe heart failure (NYHA class IV).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Delle Marche

    Ancona, Italy

  • Azienda Sanitaria Locale Bari

    Bari, Italy

  • Azienda USL IRCCS Di Reggio Emilia

    Reggio Emilia, Italy

  • Azienda USL Toscana Centro

    Florence, Italy

  • Azienda USL Toscana Nord Ovest - Cecina

    Cecina, Italy

  • Centro Cardiologico Monzino

    Milan, Italy

  • Fondazione Policlinico Universitario Campus Bio-medico

    Roma, Italy

  • Fondazione Toscana Gabriele Monasterio

    Pisa, Italy

  • IRCCS Policlinico San Donato

    San Donato Milanese, MILANO, 20097, Italy

  • Istituto Auxologico Italiano

    Milan, Italy

  • Ospedale S. Maria delle Croci

    Ravenna, Italy

  • Ospedale San Camillo Forlanini

    Roma, Italy

  • Ospedale Universitario di Ferrara

    Ferrara, Italy

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