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Study on the Effects of Semaglutide and Diet on Physical and Heart Health in Patients with Obesity and Heart Failure

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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 weight loss in patients who have both obesity and heart failure with reduced ejection fraction. The treatment being tested is a medication called Wegovy, which contains the active substance semaglutide. This medication is administered as a solution for injection using a pre-filled pen. The study aims to determine if weight loss achieved with semaglutide is more effective than weight loss through a calorie-restricted diet in improving physical performance, specifically by measuring peak oxygen uptake, which is an indicator of how well the heart and lungs work during exercise.

Participants in the study will receive different doses of Wegovy, ranging from 0.25 mg to 2.4 mg, over a period of up to 52 weeks. The medication is given through a subcutaneous injection, which means it is injected under the skin. Throughout the study, participants' physical performance and heart function will be monitored to assess the impact of weight loss on their health. The study will also compare the effects of weight loss on quality of life, exercise capacity, heart size, and certain blood markers that indicate heart health.

The purpose of this study is to explore whether a modern weight loss program using semaglutide can safely and effectively improve the health of patients with obesity and heart failure. The study will help to understand the potential benefits of this treatment approach in managing these conditions. Participants will be closely monitored to ensure their safety and to gather valuable information about the treatment's effects.

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
Participation begins after providing informed consent. This is a formal agreement to take part in the study after understanding its purpose and procedures.
Eligibility criteria include being over 18 years old, having a body mass index (BMI) of 30 kg/m² or more, and having heart failure with reduced ejection fraction (EF of 40% or less).
Step 2
Initial assessment
An initial assessment is conducted to evaluate physical and cardiac performance. This includes tests like echocardiography or cardiac magnetic resonance to confirm heart failure status.
Step 3
Medication administration
The medication semaglutide is administered through subcutaneous injection. The dosage starts with Wegovy 0.25 mg solution for injection in a pre-filled pen.
The dosage is gradually increased over time to Wegovy 1 mg, 1.7 mg, and finally 2.4 mg solution for injection, depending on the study protocol.
Step 4
Ongoing monitoring
Regular monitoring of physical performance and heart function is conducted throughout the study. This includes measuring peak oxygen uptake, which is a marker of physical performance.
Quality of life is assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Step 5
Final assessment
At the end of the 52-week period, a final assessment is conducted to measure changes in peak oxygen uptake and other health markers.
The study aims to determine if weight loss with semaglutide is more effective than a calorie-restricted diet in improving physical performance.

Who can join the trial?

5 criteria

Provide informed consent before any trial-related activities. This means you agree to participate after understanding the study details.
Be over 18 years old at the time of joining the study.
Have a Body Mass Index (BMI) of 30 or higher. BMI is a measure that uses your height and weight to estimate body fat.
Have heart failure with reduced ejection fraction. This means your heart doesn't pump blood as well as it should, with an ejection fraction of 40% or less. This is confirmed by tests like echocardiography (an ultrasound of the heart) or cardiac magnetic resonance (a detailed heart scan).
Be on a stable and optimal treatment for heart failure for at least 4 weeks. This means your medication and treatment plan have not changed recently.

Who cannot join the trial?

3 criteria

Patients who do not have obesity and heart failure with reduced ejection fraction cannot participate. Heart failure with reduced ejection fraction means the heart is not pumping blood as well as it should.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like children or pregnant women.

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Hvidovre Hospital
Hvidovre, Denmark

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Investigated drugs

Semaglutide
is a medication used in this trial to help with weight loss. It is being tested to see if it can improve physical performance in patients who have both obesity and heart failure. The goal is to determine if semaglutide can help these patients by increasing their peak oxygen uptake, which is an important measure of how well the heart and lungs work during exercise.
Calorie Restricted Diet
is another approach being used in the trial to promote weight loss. This involves reducing the number of calories consumed daily to help patients lose weight. The trial aims to compare the effects of this diet with those of semaglutide to see which method is more effective in improving physical performance in patients with obesity and heart failure.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is administered via subcutaneous injection and is currently being studied for its effects on weight loss in patients with obesity and heart failure with reduced ejection fraction. It is a medication that has gained attention in medical literature for its potential benefits in managing these conditions. The main therapeutic indication for semaglutide in this context is to aid in weight loss, which may improve physical and cardiac performance. At the molecular level, semaglutide works by mimicking a hormone called GLP-1, which helps regulate appetite and insulin secretion. It is classified pharmacologically as a GLP-1 receptor agonist.

Investigated diseases

Obesity
Obesity is a condition characterized by excessive body fat accumulation that may impair health. It is typically measured using the Body Mass Index (BMI), where a BMI of 30 or higher is considered obese. Obesity develops over time due to a combination of genetic, behavioral, and environmental factors. It can lead to various health issues, including heart disease, diabetes, and joint problems. The progression of obesity can be influenced by lifestyle choices, such as diet and physical activity levels. Managing obesity often involves lifestyle changes to reduce weight and improve overall health.
Heart Failure with Reduced Ejection Fraction
Heart failure with reduced ejection fraction (HFrEF) is a condition where the heart muscle is weakened and cannot pump blood efficiently. This results in a lower ejection fraction, which is the percentage of blood leaving the heart each time it contracts. Symptoms may include shortness of breath, fatigue, and fluid retention. The condition can develop due to damage from a heart attack, high blood pressure, or other heart-related issues. Over time, the heart's ability to pump blood effectively diminishes, leading to worsening symptoms. Management focuses on improving heart function and alleviating symptoms.