Mechanisms of Semaglutide Therapy in Heart Failure Patients
NCT Number: NCT06541509
Acronym: SEMAHEART
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: Heart Failure|Obesity
Interventions: DRUG: Semaglutide
Sponsor: University Medical Centre Ljubljana
Collaborators: Stanford University|Greenstone Biosciences
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 10
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-10
Completion Date: 2025-09-01
Locations: Greenstone Biosciences, Palo Alto, California, 94304, United States|Stanford Cardiovascular Institute, Stanford, California, 94305, United States|University Medical Center Ljubljana, Ljubljana, 1000, Slovenia

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.

Primary Outcome Measures: Interleukin-6 (IL-6), Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL)., 4 months|Interleukin-8 (IL-8), Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL)., 4 months|Tumor Necrosis Factor-alpha (TNF-α), Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL)., 4 months|Interferon-gamma (IFN-γ), Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL)., 4 months|B-type Natriuretic Peptide (BNP), Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL)., 4 months|C-reactive Protein (CRP), Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL)., 4 months|Hemoglobin A1C (HgA1C), Measured using standard laboratory methods. Units of Measure: percent (%)., 4 months|Complete Blood Count (CBC), Measured using automated hematology analyzer. CBC parameters will be measured in their respective units (e.g., cells per microliter)., 4 months|Comprehensive Metabolic Panel (Chem 7), Measured using standard laboratory methods. Chem 7 parameters will be measured in their respective units (e.g., mg/dL, U/L)., 4 months|Liver Function Tests (LFT), Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg/dL, U/L)., 4 months|Body mass index, 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., 4 months
Secondary Outcome Measures: Left ventricular end-systolic volume (LVESV), Measured using echocardiography. Units of measure: mililiter (mL), 4 months|Left ventricular end-diastolic volume (LVEDV), Measured using echocardiography. Units of measure: mililiter (mL), 4 months|Myocardial mass, Measured using echocardiography. Units of measure: gram (g), 4 months|Left ventricular ejection fraction (LVEF), Measured using echocardiography. Units of measure: percent (%), 4 months|Left ventricular filling pressures (E/e'), Measured using echocardiography. Units of measure: numerical value, 4 months|Global longitudinal strain (GLS), Measured using echocardiography. Units of measure: percent (%), 4 months|Exercise capacity, Measured by 6-minute walk test distance Units of measure: meter (m), 4 months|Lean body mass, Measured using dual-energy X-ray absorptiometry Units of measure: gram (g), 4 months|Fat mass, Measured using dual-energy X-ray absorptiometry Units of measure: gram (g), 4 months