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Study on the Effects of Dapagliflozin for Patients with Heart Failure with Preserved Ejection Fraction

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 Forxiga, which contains the active ingredient dapagliflozin. The study is investigating its impact on a condition known as heart failure with preserved ejection fraction (HFpEF). This type of heart failure occurs when the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats, leading to symptoms like shortness of breath and fatigue.

The purpose of the study is to understand how dapagliflozin can benefit patients with HFpEF. Participants in the study will take Forxiga in the form of film-coated tablets. The study will explore how the medication affects the heart's function and structure over time. This includes looking at how the heart muscle relaxes and contracts, as well as changes in heart size and shape using imaging techniques like MRI and echocardiography. The study will also examine changes at the cellular level, such as heart muscle cell stiffness and the presence of certain proteins.

Throughout the study, participants will be monitored to see how their heart condition responds to the treatment. The study aims to provide insights into the biological and mechanical processes that contribute to the benefits of dapagliflozin in managing HFpEF. This research could help improve understanding and treatment of this type of heart failure in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, heart function, and medical history related to heart failure with preserved ejection fraction (HFpEF).

  2. Step 2

    Medication administration

    The medication Forxiga (dapagliflozin) is administered. This is a 10 mg film-coated tablet taken orally once daily. The duration of administration is determined by the study protocol.

  3. Step 3

    Regular monitoring

    Regular monitoring is conducted to assess heart function and overall health. This includes echocardiograms and possibly cardiac catheterization if clinically indicated.

  4. Step 4

    Primary evaluation

    The primary evaluation focuses on heart function, specifically measuring systolic and diastolic properties through pressure-volume curve analysis.

  5. Step 5

    Secondary evaluation

    Secondary evaluations include imaging tests like cardiac MRI to assess heart structure and function, as well as blood tests to analyze biomarkers related to heart health.

  6. Step 6

    Final assessment

    A final assessment is conducted to evaluate the overall effects of the medication on heart function and to gather data on any changes in heart structure or biomarkers.

Who can join the trial?

10 criteria

  • Adults of both genders who are **18 years or older** can participate.
  • Participants must have a **Left Ventricular Ejection Fraction (LVEF)** of **50% or higher**. This is a measure of how well the heart is pumping blood.
  • Participants should have a diagnosis of **Heart Failure with preserved Ejection Fraction (HFpEF)**. This means the heart has trouble relaxing and filling with blood.
  • Participants should have a history of being hospitalized or needing **intravenous diuretic treatment** in the last 6 months. Diuretics are medicines that help remove excess fluid from the body.
  • Participants must show evidence of **diastolic dysfunction** based on an **echocardiogram**. This is a test that uses sound waves to create pictures of the heart.
  • Participants can have **Type II Diabetes Mellitus** or not. This is a condition where the body has trouble using sugar for energy.
  • Participants should be in a **clinically stable condition**, meaning they have been stable for more than 1 month after a hospital stay for heart failure or since their last dose of intravenous diuretics.
  • Participants must have a **clinical indication for cardiac catheterization**. This is a procedure to examine how well the heart is working.
  • Participants must have a **clinical indication to start new treatment with SGLT2 inhibitors**. These are medications that help lower blood sugar levels.
  • Participants must provide **signed informed consent**, which means they agree to participate in the study after understanding all the details.

Who cannot join the trial?

4 criteria

  • Patients with a condition called heart failure with preserved ejection fraction cannot participate. This means the heart is not pumping as well as it should, but the amount of blood being pumped out is normal.
  • Individuals who are not within the specified age range for the study cannot participate. The study is looking for participants in certain age groups.
  • People who belong to certain clinical trial groups that are not included in this study cannot participate.
  • Participants who are part of a vulnerable population, which means they might need special protection or care, are not eligible for this study.
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Investigated drugs

Sodium-glucose cotransporter 2 inhibitor (iSGLT2) is a type of medication used in this trial to study its effects on heart failure with preserved ejection fraction. This medication works by helping the kidneys remove glucose from the bloodstream through urine. It is being investigated for its potential benefits on heart function and overall cardiovascular health in patients with this type of heart failure.

What is already known about the treatment

Sodium-Glucose Cotransporter 2 Inhibitors (iSGLT2) – These medications are typically administered orally in tablet form. They are currently being studied for their effects on heart failure with preserved ejection fraction, a condition where the heart muscle contracts normally but the ventricles do not relax as they should. iSGLT2 inhibitors are primarily used to manage blood sugar levels in type 2 diabetes but are now being explored for cardiovascular benefits. They work by blocking the reabsorption of glucose in the kidneys, leading to increased glucose excretion in the urine. This class of drugs is known for its role in the management of diabetes and is gaining attention for potential heart-related benefits.

Investigated diseases

Heart Failure with Preserved Ejection Fraction – This condition occurs when the heart's lower chambers, known as ventricles, are unable to relax and fill properly with blood, despite the heart's ability to pump blood effectively. It is characterized by symptoms such as shortness of breath, fatigue, and fluid retention. The heart muscle may become stiff or thickened, leading to increased pressure in the heart and lungs. Over time, this can result in reduced exercise capacity and difficulty in performing daily activities. The condition is often associated with other health issues like high blood pressure, obesity, and diabetes. It is a chronic condition that requires ongoing management to alleviate symptoms and improve quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520969-51-00Protocol codeFIBHGM-ECNC001-2019Estimated enrolment20 patientsSponsorFundacion Para La Investigacion Biomedica Del Hospital Gregorio Maranon

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