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

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What is this study about?

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.

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 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 regular monitoring

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

4 primary evaluation

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

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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hospital General Universitario Gregorio Maranon Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Spain Spain
Not yet recruiting
01.06.2023

Trial locations

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.

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 ID:
2025-520969-51-00
Protocol code:
FIBHGM-ECNC001-2019
Trial Phase:
Therapeutic confirmatory (Phase III)

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