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Study on the Effect of Empagliflozin, Acetylcholine Chloride, Insulin Aspart, and Sodium Nitroprusside Dihydrate on Heart Failure with Preserved Ejection Fraction Patients

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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 the medication empagliflozin on a condition known as heart failure with preserved ejection fraction (HFpEF). Heart failure with preserved ejection fraction is a type of heart failure where the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats. The medication being tested, empagliflozin, is a type of drug known as an SGLT-2 inhibitor, which is commonly used to help manage blood sugar levels in people with diabetes. In this study, empagliflozin is being used to see if it can improve blood flow in small blood vessels in the skin of patients with HFpEF.

The purpose of the study is to evaluate how empagliflozin affects the function of small blood vessels in the skin, known as peripheral microvascular function, after three months of treatment. This is measured by looking at how well blood flows through the skin on the forearm. The study uses a special technique called laser speckle contrast analysis (LASCA) to measure this blood flow. During the study, participants will receive empagliflozin and may also be exposed to substances like acetylcholine chloride, insulin aspart, and sodium nitroprusside dihydrate to help assess the blood flow response.

Participants in the study will take empagliflozin in the form of a 10 mg film-coated tablet once daily for a period of three months. The study will monitor changes in blood flow and other health indicators to understand the impact of the medication on heart failure with preserved ejection fraction. The study aims to provide insights into whether empagliflozin can be beneficial for patients with this type of heart failure by improving the function of small blood vessels in the skin.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be required to provide a signed informed consent. This confirms your understanding and agreement to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your diagnosis of heart failure with preserved ejection fraction (HFpEF) according to the ESC 2021 Guidelines. This may involve reviewing your medical history and conducting necessary tests.
Step 3
Medication administration
You will begin treatment with empagliflozin, which is a medication taken orally. The dosage is 10 mg once daily. This treatment will continue for a duration of 3 months.
Step 4
Regular monitoring
Throughout the trial, your health and response to the medication will be regularly monitored. This includes measuring your cutaneous vascular conductance (CVC) in the forearm skin using a technique called laser speckle contrast analysis (LASCA).
During these assessments, substances such as acetylcholine chloride, insulin aspart, and sodium nitroprusside dihydrate will be applied topically to your skin to evaluate your microvascular function.
Step 5
Completion of the trial
At the end of the 3-month period, a final assessment will be conducted to evaluate the effects of the treatment. This will include measuring your CVC and other health indicators such as serum ketone levels and completing a quality of life questionnaire (EQ5D-5L).

Who can join the trial?

6 criteria

Diagnosis of HFpEF (Heart Failure with Preserved Ejection Fraction) according to the 2021 guidelines from the European Society of Cardiology.
Ability to understand and speak the Dutch language.
Plan to start treatment with empagliflozin 10mg once daily, as decided by the treating doctor.
Signed informed consent, which means you agree to participate in the study after being informed about it.
Both men and women can participate.
Participants should be adults, typically aged 18 years and older.

Who cannot join the trial?

10 criteria

Patients with any other serious heart conditions besides heart failure with preserved ejection fraction cannot participate.
Individuals with severe kidney problems are excluded.
People with uncontrolled high blood pressure are not eligible.
Patients who have had a heart attack in the last 3 months cannot join.
Individuals with severe liver disease are excluded.
People with a history of severe allergic reactions to the study medication cannot participate.
Pregnant or breastfeeding women are not eligible.
Participants in another clinical trial within the last 30 days are excluded.
Individuals with a history of drug or alcohol abuse in the past year cannot join.
Patients with any condition that the study doctors believe would make participation unsafe are excluded.

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Academisch Ziekenhuis Maastricht
Maastricht, The Netherlands

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Investigated drugs

Empagliflozin is a medication used in this clinical trial to help improve blood flow in small blood vessels in the skin of patients with a specific type of heart failure. This type of heart failure is called heart failure with preserved ejection fraction, or HFpEF. Empagliflozin works by helping the body remove excess sugar through urine, which can also help reduce the workload on the heart and improve circulation. In this study, researchers are looking at how empagliflozin affects the tiny blood vessels in the skin of the forearm after three months of treatment.

What is already known about the treatment

Empagliflozin – Empagliflozin is a medication taken orally, typically in the form of a tablet. It is currently being studied for its effects on heart failure with preserved ejection fraction, a condition where the heart pumps normally but is too stiff to fill properly. The main therapeutic use of empagliflozin is to improve heart function by enhancing blood flow in small blood vessels. At the molecular level, it works by inhibiting a protein called SGLT-2, which helps the kidneys remove excess glucose from the blood. Empagliflozin belongs to a class of drugs known as SGLT-2 inhibitors, which are primarily used to manage blood sugar levels in people with type 2 diabetes.

Investigated diseases

Heart failure with preserved ejection fraction – This condition occurs when the heart muscle contracts normally but the ventricles do not relax as they should during heartbeats. This leads to a situation where the heart cannot fill with enough blood, causing a backup of blood in the lungs and other parts of the body. Patients may experience symptoms such as shortness of breath, fatigue, and swelling in the legs and feet. The disease progresses as the heart's ability to fill with blood becomes increasingly impaired, leading to more pronounced symptoms. Over time, the heart's efficiency in pumping blood diminishes, affecting overall circulation. The condition is often associated with other health issues like high blood pressure and diabetes.