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A Study Testing Drug Combination for Heart Failure in Women Comparing Increased Doses to Standard Care

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Heart Failure, which is a condition where the heart cannot pump blood effectively enough to meet the body's needs. This can cause symptoms like shortness of breath, tiredness, and swelling in the legs and ankles. The study will examine the use of several medications that are commonly prescribed to treat this condition. These medications include spironolactone, losartan, trandolapril, enalapril, olmesartan, irbesartan, bisoprolol, sacubitril valsartan, nebivolol, ramipril, valsartan, perindopril, candesartan, canrenone, carvedilol, finerenone, empagliflozin, quinapril, fosinopril, metoprolol, dapagliflozin, captopril, lisinopril, eplerenone, and potassium canrenoate. The purpose of the study is to understand how well these life-saving medications are being used in women with heart failure and to determine if increasing the doses of these medications can improve health outcomes compared to usual care.

The study has two parts. The first part looks back at medical records to understand the current state of heart failure treatment and identify any differences in how men and women receive care. The second part is a forward-looking trial involving women between 18 and 85 years old who have been hospitalized for heart failure. These women will be divided into two groups: one group will receive increased doses of their heart failure medications following a specific treatment plan, while the other group will continue with their usual care. The study will track participants for 12 months to see how the different approaches affect their health.

During the study, researchers will measure several outcomes including death from any cause, hospital readmission for heart failure, and worsening heart failure symptoms. They will also assess quality of life using a questionnaire, how well participants stick to their medication, and any side effects experienced. Additional measurements will include changes in blood test markers and outcomes in specific groups of patients such as those with different levels of heart function, different ages, or those with diabetes, kidney disease, or obesity. The study aims to determine whether optimizing medication doses in women with heart failure can reduce illness and death, improve quality of life, and help identify the best treatment approach for this patient group.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Hospital admission and initial assessment

    Your participation begins during a hospital stay for acute heart failure, which is a sudden worsening of heart failure symptoms. This admission occurs within 24 to 48 hours before the initial screening.

    During this time, you experience shortness of breath at rest and fluid buildup in the lungs visible on chest X-ray. Other symptoms may include swelling and abnormal lung sounds when examined with a stethoscope.

    Medical staff will measure your blood pressure, which must be at least 100 mmHg, and your heart rate, which must be at least 60 beats per minute.

    A blood test will check your potassium level, which must be 5.0 mEq/L or lower.

    Blood tests will also measure NT-proBNP, a substance in the blood that indicates heart stress. At this stage, the level must be above 1,800 pg/mL (or 2,350 pg/mL if you have an irregular heart rhythm called atrial fibrillation).

  2. Step 2

    Pre-discharge evaluation

    One to two days before leaving the hospital, additional measurements will be taken.

    Your blood pressure must still be at least 100 mmHg and your heart rate at least 60 beats per minute within 24 hours before this assessment.

    Your potassium level must remain at 5.0 mEq/L or lower within 24 hours before this assessment.

    Another NT-proBNP blood test will be performed. At this point, the level must be above 1,000 pg/mL (or 1,300 pg/mL if you have atrial fibrillation) to confirm that heart stress persists.

    Your current heart failure medications will be reviewed. If your heart's pumping ability is reduced (measured as ejection fraction below 50%), you should be taking less than half the optimal dose of medications including ACE inhibitors (such as enalapril, ramipril, lisinopril, quinapril, trandolapril, fosinopril, or captopril), ARBs (such as losartan, valsartan, candesartan, irbesartan, or olmesartan), ARNIs (sacubitril valsartan), mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, canrenone, potassium canrenoate, or finerenone), and beta-blockers (such as bisoprolol, nebivolol, carvedilol, or metoprolol).

    If your heart's pumping ability is preserved (ejection fraction above 50%), you should be taking less than half the optimal dose of mineralocorticoid receptor antagonists.

  3. Step 3

    Assignment to treatment approach

    You will be assigned to one of two approaches: either a program to gradually increase your heart failure medications following a specific schedule, or continuation of your usual care.

    This assignment determines how your medications will be managed over the following year.

  4. Step 4

    Medication adjustment period

    If assigned to the medication increase program, your doses of heart failure medications will be gradually adjusted over time.

    The medications involved may include ACE inhibitors (captopril, enalapril, fosinopril, lisinopril, quinapril, ramipril, or trandolapril), ARBs (candesartan, irbesartan, losartan, olmesartan, or valsartan), ARNIs (sacubitril valsartan), beta-blockers (bisoprolol, carvedilol, metoprolol, or nebivolol), mineralocorticoid receptor antagonists (canrenone, eplerenone, finerenone, potassium canrenoate, or spironolactone), and SGLT2 inhibitors (dapagliflozin or empagliflozin).

    All medications are taken by mouth.

    The specific doses, frequency, and duration of each medication will be determined individually based on your response and tolerance.

    If assigned to usual care, your medications will be managed according to standard practice without following the specific increase program.

  5. Step 5

    Follow-up period over 12 months

    Your health will be monitored for one year after assignment to your treatment approach.

    During this time, information will be collected about hospital readmissions for heart failure, worsening of heart failure symptoms, and survival.

    Your quality of life will be assessed using a standardized questionnaire.

    Information will be gathered about whether you continue taking your medications as prescribed or if doses are reduced or stopped.

    Any unwanted effects from the medications will be recorded.

    Blood tests may be performed to measure biomarkers, which are substances in the blood that provide information about your heart condition.

    Changes in your heart's pumping ability may be assessed through imaging tests.

Who can join the trial?

12 criteria

  • You must be a female patient between 18 and 85 years old
  • You must have been admitted to the hospital within 24 to 48 hours before the screening visit for acute heart failure, which means sudden worsening of heart failure with difficulty breathing while resting
  • You must have pulmonary congestion on chest X-ray, which means fluid buildup in the lungs visible on the X-ray image
  • You must have other signs or symptoms of heart failure such as swelling in your body or abnormal lung sounds when the doctor listens with a stethoscope
  • Your systolic blood pressure, which is the top number in a blood pressure reading, must be 100 mmHg or higher in all measurements taken within 24 hours before starting the study treatment
  • Your heart rate, which is how many times your heart beats per minute, must be 60 beats per minute or higher in all measurements taken within 24 hours before starting the study treatment
  • Your blood potassium level, which is an important mineral in your blood, must be 5.0 mEq/L or lower in all measurements taken within 24 hours before starting the study treatment
  • At the screening visit, your NT-proBNP level, which is a blood test that shows heart stress, must be higher than 1,800 pg/mL, or higher than 2,350 pg/mL if you have atrial fibrillation, which is an irregular heart rhythm
  • At the time of starting the study treatment, which is 1 to 2 days before leaving the hospital, your NT-proBNP level must be higher than 1,000 pg/mL, or higher than 1,300 pg/mL if you have atrial fibrillation
  • If your ejection fraction, which measures how well your heart pumps blood, is less than 50 percent, you must be taking less than half of the recommended dose of certain heart failure medications including ACE inhibitors, ARBs, ARNIs, MRAs, and beta blockers
  • If your ejection fraction is greater than 50 percent, you must be taking less than half of the recommended dose of MRA medication
  • You must be willing and able to provide written informed consent, which means you agree in writing to participate in the study after understanding all the details

Who cannot join the trial?

3 criteria

  • Men cannot participate in this study, as it is only for female patients
  • Children and teenagers under 18 years of age cannot participate in this study
  • People who do not have heart failure, which is a condition where the heart cannot pump blood effectively to meet the body's needs, cannot participate
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Investigated drugs

GDMT (Guideline-Directed Medical Therapy) is a combination of proven medications used to treat heart failure. These are medicines that have been shown to help people with heart failure live longer and feel better. In this study, doctors will adjust the doses of these heart failure medications to reach the best levels for each patient, following a specific treatment plan called the STRONG-HF program. The goal is to see if carefully increasing these medications to their target doses can improve outcomes for women with heart failure compared to regular care.

What is already known about the treatment

GDMT (Guideline-Directed Medical Therapy) – This refers to a combination of evidence-based medications that are recommended by clinical guidelines for treating heart failure, rather than a single drug. GDMT is the current standard of care in heart failure management and includes several classes of medications that work together to improve heart function, reduce symptoms, and increase survival rates. These medications act through various mechanisms at the molecular level, including blocking harmful stress hormones, reducing fluid buildup, and helping the heart pump more efficiently. The therapy is typically adjusted gradually to reach optimal doses that each patient can tolerate, and this trial specifically examines whether following a structured program to increase medication doses (up-titration) can improve outcomes, particularly in women with heart failure who may not always receive the same level of treatment optimization as men.

Investigated diseases

Heart Failure – Heart failure is a chronic condition where the heart muscle becomes weakened and cannot pump blood effectively throughout the body. This occurs when the heart is unable to fill with enough blood or lacks sufficient strength to circulate blood to meet the body's needs. As the condition progresses, the body may retain fluid, leading to swelling in the legs, ankles, and abdomen. Patients often experience shortness of breath, especially during physical activity or while lying down, along with persistent fatigue and weakness. The heart tries to compensate by enlarging, developing more muscle mass, or pumping faster, but these adaptations eventually fail. Over time, heart failure can affect other organs such as the kidneys and liver due to reduced blood flow and fluid buildup.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520660-18-00Protocol codeAIFA-CARDIO-129Estimated enrolment368 patientsSponsorPoliclinico San Donato S.p.A.

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