A Pilot Clinical Trial Investigating Underlying Mechanisms of Semaglutide Therapy in Heart Failure Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- B-type Natriuretic Peptide (BNP)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Presence of type 1 or type 2 diabetes or glycated haemoglobin higher than 6.5%
- •Pregnancy or potential to become pregnant
- •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
研究组 & 干预措施
Semaglutide Therapy
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
干预措施: Semaglutide (Drug)
结局指标
主要结局
B-type Natriuretic Peptide (BNP)
时间窗: 4 months
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Interleukin-6 (IL-6)
时间窗: 4 months
Measured using enzyme linked immunosorbent assay (ELISA). Units of Measure: picograms per milliliter (pg/mL).
Complete Blood Count (CBC)
时间窗: 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)
时间窗: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
C-reactive Protein (CRP)
时间窗: 4 months
Measured using immunoassay. Units of Measure: picograms per milliliter (pg/mL).
Interleukin-8 (IL-8)
时间窗: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Comprehensive Metabolic Panel (Chem 7)
时间窗: 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
时间窗: 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)
时间窗: 4 months
Measured using ELISA. Units of Measure: picograms per milliliter (pg/mL).
Hemoglobin A1C (HgA1C)
时间窗: 4 months
Measured using standard laboratory methods. Units of Measure: percent (%).
Liver Function Tests (LFT)
时间窗: 4 months
Measured using standard laboratory methods. LFT parameters will be measured in their respective units (e.g., mg/dL, U/L).
次要结局
- Left ventricular filling pressures (E/e')(4 months)
- Myocardial mass(4 months)
- Global longitudinal strain (GLS)(4 months)
- Exercise capacity(4 months)
- Left ventricular end-systolic volume (LVESV)(4 months)
- Lean body mass(4 months)
- Left ventricular ejection fraction (LVEF)(4 months)
- Left ventricular end-diastolic volume (LVEDV)(4 months)
- Fat mass(4 months)