RecruitingPhase 1Phase 2NCT06541509

Mechanisms of Semaglutide Therapy in Heart Failure Patients

A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients

Sponsor

University Medical Centre Ljubljana

Enrollment

10 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Heart Failure Obesity

Summary

Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist, primarily used for treatment of type-2 diabetes mellitus. GLP-1 receptors are present on pancreatic islet β-cells, δ-cells and α-cells. Their stimulation increases insulin and somatostatin secretion, and decreases glucagon secretion. In addition, GLP-1 receptor agonists appear to have multiple extrapancreatic actions, which remain poorly defined. In large clinical trials, semaglutide improved the outcomes in obese patients, patients with heart failure with preserved ejection fraction, and decreased the heart failure hospitalizations in patients with type 2 diabetes. The aim of the present study is to investigate the underlying mechanisms of the beneficial clinical effects of semaglutide in the setting of chronic heart failure.

Eligibility

Min Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying how semaglutide — a medication known for weight loss and blood sugar control (sold under brand names like Ozempic and Wegovy) — works in people with heart failure who are overweight but do not have diabetes. Researchers want to understand the biological mechanisms behind why semaglutide seems to benefit heart failure patients. **You may be eligible if...** - You are 20–80 years old with a diagnosis of heart failure - Your body mass index (BMI) is 27 or higher (overweight or obese) - Your heart failure treatment has been stable for at least 3 months - Your NT-proBNP level (a marker of heart stress) is above 350 pg/mL **You may NOT be eligible if...** - You have type 1 or type 2 diabetes, or your HbA1c is above 6.5% - You are pregnant or could become pregnant - You have cancer, liver dysfunction, or severe kidney disease - You were hospitalized for heart failure in the past 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSemaglutide

10 overweight patients with heart failure will be enrolled, including 5 patients with heart failure with preserved ejection fraction (HFpEF) and 5 patients with heart failure with reduced ejection fraction (HFrEF). The diagnosis of HFpEF and HFrEF will be based on the most recent European Society of Cardiology guidelines for the diagnosis and treatment of heart failure. After their baseline blood sample collections, all participants will receive once-weekly subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) at a dose of 0.25 mg for 2 weeks, 0.5 mg for 2 weeks, and then 1.0 mg for a period of 12 weeks. At the end of the 3-month and 4-month period, blood sample collections will be repeated. All blood samples will be sent to Stanford Cardiovascular Institute for further analyses. At baseline, and again at 4 months transthoracic echocardiography, 6-minute walk test, and body composition assessment will be performed.