Mechanisms of Semaglutide Therapy in Heart Failure Patients
- Registration Number
- NCT06541509
- Lead Sponsor
- University Medical Centre Ljubljana
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Age: 20-80 years
- Presence of heart failure
- Body-mass index 27 kg/m2 or greater
- Stable optimally tolerated dosages of heart failure therapies for 3 months
- N-terminal pro B-type natriuretic peptide levels >350 pg/mL
- Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%
- Pregnancy or potential to become pregnant
- Cancer
- Liver dysfunction (aspartate aminotransferase and/or alanine aminotransferase > 3 times upper limits of normal or total bilirubin greater than 1.5 times upper limits of normal)
- Renal dysfunction (estimated glomerular filtration rate less than 25 mL/min/1.73 m2)
- Hospitalization in the past 3 months for reasons other than heart failure
- New York Heart Association (NYHA) functional class I or functional class IV symptoms.
- Prior or planned bariatric surgery
- Self-reported change in body weight >11 lbs (5 kg) within 3 months before enrollment
- Acute or chronic infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Semaglutide Therapy Semaglutide Timepoints: * Baseline (Week 0) * Week 2 (Visit 1) * Week 4 (Visit 2) * Week 12 (Visit 3) * Week 16 (Visit 4) Medication Schedule: Subcutaneous semaglutide (Ozempyc, Novo Nordisk A/S Bagsvaerd, Denmark) First 2 weeks: Semaglutide; 0.25 mg weekly Second 2 weeks: Semaglutide; 0.5 mg weekly Remaining 12 weeks: Semaglutide; 1 mg weekly
- Primary Outcome Measures
Name Time Method B-type Natriuretic Peptide (BNP) 4 months Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Interleukin-6 (IL-6) 4 months Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).
Complete Blood Count (CBC) 4 months Measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter).
Interferon-gamma (IFN-γ) 4 months Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
C-reactive Protein (CRP) 4 months Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Interleukin-8 (IL-8) 4 months Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Comprehensive Metabolic Panel (Chem 7) 4 months Measured using standard laboratory methods. Chem 7 parameters will be measured in their respective units (e.g., mg/dL, U/L).
Body mass index 4 months Patient weight will be measured in kilograms and height will be measured in meters. Body mass index (BMI) will be calculated according to the standard formula: weight in kilograms divided by height in meters squared.
Tumor Necrosis Factor-alpha (TNF-α) 4 months Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Hemoglobin A1C (HgA1C) 4 months Measured using standard laboratory methods. Units of Measure: percent (%).
Liver Function Tests (LFT) 4 months Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg/dL, U/L).
- Secondary Outcome Measures
Name Time Method Left ventricular filling pressures (E/e') 4 months Measured using echocardiography. Units of measure: numerical value
Myocardial mass 4 months Measured using echocardiography. Units of measure: gram (g)
Global longitudinal strain (GLS) 4 months Measured using echocardiography. Units of measure: percent (%)
Exercise capacity 4 months Measured by 6-minute walk test distance Units of measure: meter (m)
Left ventricular end-systolic volume (LVESV) 4 months Measured using echocardiography. Units of measure: mililiter (mL)
Lean body mass 4 months Measured using dual-energy X-ray absorptiometry Units of measure: gram (g)
Left ventricular ejection fraction (LVEF) 4 months Measured using echocardiography. Units of measure: percent (%)
Left ventricular end-diastolic volume (LVEDV) 4 months Measured using echocardiography. Units of measure: mililiter (mL)
Fat mass 4 months Measured using dual-energy X-ray absorptiometry Units of measure: gram (g)
Trial Locations
- Locations (3)
University Medical Center Ljubljana
🇸🇮Ljubljana, Slovenia
Greenstone Biosciences
🇺🇸Palo Alto, California, United States
Stanford Cardiovascular Institute
🇺🇸Stanford, California, United States