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Study on the Effects of Sacubitril and Valsartan in Patients with Heart Failure and Mitral Valve Regurgitation

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Entresto, which contains the active substances valsartan and sacubitril, on patients with a specific type of heart condition known as Heart Failure with Preserved Ejection Fraction (HFpEF) and a related issue called Secondary Mitral Valve Regurgitation. Heart failure with preserved ejection fraction is a condition where the heart's pumping ability is normal, but it has trouble relaxing and filling with blood. Secondary mitral valve regurgitation occurs when the heart's mitral valve doesn't close tightly, allowing blood to flow backward in the heart.

The purpose of this study is to assess how Entresto affects the heart's function in these patients. Participants in the study will take Entresto in the form of film-coated tablets, which are taken orally. The study will last for about six months, during which time the effects of the medication on heart function will be monitored. Some participants may receive a placebo, which is a tablet that looks like the medication but does not contain the active substances.

Throughout the study, various tests will be conducted to evaluate heart function, including a combination of exercise testing and imaging techniques. These tests will help determine how the medication affects the heart's ability to pump blood and the severity of the mitral valve regurgitation. The study will also look at changes in participants' quality of life and other health indicators. The goal is to better understand how Entresto can help manage these heart conditions and improve patient outcomes.

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

    Joining the study

    Upon joining the study, the patient will be informed about the trial's purpose and procedures. The patient must provide written consent to participate.

    Eligibility criteria include being over 18 years old, having a specific heart condition, and meeting certain health parameters.

  2. Step 2

    Initial assessment

    The patient will undergo initial assessments, including cardiopulmonary exercise testing and stress echocardiography. These tests help evaluate heart function and structure.

  3. Step 3

    Medication administration

    The patient will begin taking Entresto, which contains the active substances valsartan and sacubitril. The medication is administered orally in the form of film-coated tablets.

    Dosage options include 24 mg/26 mg, 49 mg/51 mg, or 97 mg/103 mg tablets. The specific dosage and frequency will be determined by the study protocol and the patient's condition.

  4. Step 4

    Ongoing monitoring

    Throughout the study, the patient will be monitored regularly to assess the effects of the medication. This includes repeated cardiopulmonary exercise testing and stress echocardiography.

    The study aims to observe changes in heart function, quality of life, and other health parameters over time.

  5. Step 5

    Final assessment

    At the end of the study period, which is estimated to conclude by September 2025, the patient will undergo a final assessment to evaluate the overall impact of the treatment.

    The primary focus will be on changes in heart function and other key health indicators.

Who can join the trial?

6 criteria

  • Must be over 18 years old.
  • Must have a condition classified as NYHA class II to IV. This is a way to describe how severe heart failure symptoms are, with class II being mild and class IV being severe.
  • Must provide written informed consent, which means agreeing to participate after understanding the study details.
  • Must have a left ventricular ejection fraction of 50% or higher. This is a measure of how well the heart pumps blood.
  • Must have objective evidence of heart structure or function problems that suggest issues with the heart's ability to fill with blood, known as LV diastolic dysfunction or raised LV filling pressures. This includes having high levels of certain substances in the blood called **natriuretic peptides**, which are markers of heart stress.
  • Must have moderate or greater functional mitral regurgitation, which is a condition where the heart's mitral valve doesn't close properly, allowing blood to flow backward. This must be confirmed by a test called TTE (transthoracic echocardiogram) within the past year.

Who cannot join the trial?

5 criteria

  • Patients who do not have heart failure with preserved ejection fraction. This means the heart is not pumping as well as it should, but the amount of blood being pumped out is still normal.
  • Patients who do not have secondary mitral valve regurgitation. This is when the heart's mitral valve doesn't close tightly, causing blood to flow backward in the heart.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to undergo the required tests, such as cardiopulmonary exercise testing and stress echocardiography. These tests check how well the heart and lungs work during exercise and how the heart functions under stress.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Sacubitril-Valsartan is a medication used in this clinical trial to study its effects on patients with heart failure with preserved ejection fraction (HFpEF) and secondary mitral valve regurgitation. This medication works by helping to relax blood vessels, which can improve blood flow and reduce the workload on the heart. The trial aims to understand how this medication affects heart function and exercise capacity in these patients.

What is already known about the treatment

Sacubitril-Valsartan – This medication is administered orally in tablet form. It is currently being studied in clinical trials for its effects on heart failure with preserved ejection fraction and secondary mitral valve regurgitation. Sacubitril-Valsartan is primarily used to treat heart failure by reducing strain on the heart and improving blood flow. At the molecular level, it works by inhibiting neprilysin and blocking angiotensin II receptors, which helps to relax blood vessels and decrease fluid retention. It is classified as an angiotensin receptor-neprilysin inhibitor (ARNI).

Investigated diseases

  • Heart Failure with Preserved Ejection Fraction

    This condition occurs when the heart's lower chambers are unable to fill properly with blood, despite the heart muscle contracting normally. It leads to symptoms like shortness of breath and fatigue, especially during physical activity. Over time, the heart's ability to pump blood efficiently is compromised, affecting overall circulation. The condition is often associated with high blood pressure and other cardiovascular issues. It progresses gradually, with symptoms worsening as the heart's function declines.

  • Secondary Mitral Valve Regurgitation

    This condition arises when the mitral valve in the heart does not close tightly, causing blood to flow backward into the left atrium. It is secondary to other heart conditions, such as heart failure, which cause changes in the heart's structure. As the condition progresses, it can lead to symptoms like fatigue and shortness of breath. The backward flow of blood can increase pressure in the heart and lungs, worsening over time. It is often linked to the enlargement of the heart chambers and changes in heart muscle function.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506634-70-00Estimated enrolment110 patientsSponsorZiekenhuis Oost Limburg

sourced from the EU Clinical Trials Register and site verification

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