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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
Greenstone Biosciences
Palo Alto, California, United States
RECRUITINGStanford Cardiovascular Institute
Stanford, California, United States
RECRUITINGUniversity Medical Center Ljubljana
Ljubljana, Slovenia
RECRUITINGInterleukin-6 (IL-6)
Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).
Time frame: 4 months
Interleukin-8 (IL-8)
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Time frame: 4 months
Tumor Necrosis Factor-alpha (TNF-α)
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Time frame: 4 months
Interferon-gamma (IFN-γ)
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Time frame: 4 months
B-type Natriuretic Peptide (BNP)
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Time frame: 4 months
C-reactive Protein (CRP)
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Time frame: 4 months
Hemoglobin A1C (HgA1C)
Measured using standard laboratory methods. Units of Measure: percent (%).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 4 months
Left ventricular end-systolic volume (LVESV)
Measured using echocardiography. Units of measure: mililiter (mL)
Time frame: 4 months
Left ventricular end-diastolic volume (LVEDV)
Measured using echocardiography. Units of measure: mililiter (mL)
Time frame: 4 months
Myocardial mass
Measured using echocardiography. Units of measure: gram (g)
Time frame: 4 months
Left ventricular ejection fraction (LVEF)
Measured using echocardiography. Units of measure: percent (%)
Time frame: 4 months
Left ventricular filling pressures (E/e')
Measured using echocardiography. Units of measure: numerical value
Time frame: 4 months
Global longitudinal strain (GLS)
Measured using echocardiography. Units of measure: percent (%)
Time frame: 4 months
Exercise capacity
Measured by 6-minute walk test distance Units of measure: meter (m)
Time frame: 4 months
Lean body mass
Measured using dual-energy X-ray absorptiometry Units of measure: gram (g)
Time frame: 4 months
Fat mass
Measured using dual-energy X-ray absorptiometry Units of measure: gram (g)
Time frame: 4 months
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