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| Name | Class |
|---|---|
| Stanford University | OTHER |
| Greenstone Biosciences | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide Therapy | Experimental | Timepoints:
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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bojan Vrtovec, MD, PhD | Contact | +3861 522 1157 | bojan.vrtovec@kclj.si | |
| Sabina Frljak, MD, PhD | Contact | +3861 522 2844 | sabina.frljak@kclj.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greenstone Biosciences | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| C000591245 | semaglutide |
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|
| 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 |
| 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 |
| Stanford Cardiovascular Institute | Recruiting | Stanford | California | 94305 | United States |
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| University Medical Center Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
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| D009748 |
| Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |