NCT05778084招募中4 期
Effect of Empagliflozin on NT-Pro Brain Natriuretic Peptide in Heart Failure Patients With Reduced Ejection Fraction
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- NT-ProBNP
研究概览
简要总结
This study aims to evaluate the relationship between NT-proBNP and empagliflozin effects in patients with chronic heart failure with mildly reduced ejection fraction (HFmrEF 41-49%) and reduced ejection fraction (HFrEF ≤40%) whether diabetic or non-diabetic patients.
详细描述
- Ethical Committee approval has been obtained from ethics committee of Faculty of Medicine, Alexandria University.
- Assigning an informed consent for agreement of participation should be taken by all participants in this clinical study.
- Heart failure patients with reduced and mildly reduced ejection fraction will be recruited from Alexandria Main University Hospital (AMUH), private hospitals and clinics.
- A Blood sample will be collected from 60 patients as baseline to test for N-terminal Pro-B-type Natriuretic Peptide.
- The same 60 patients will take Empagliflozin for 6 months.
- Another blood sample will be taken from the same 60 patients to test the effect on N-terminal Pro-B-type Natriuretic Peptide after Empagliflozin administration.
- The appropriate statistical test will be hold according to study design and parameters to evaluate the significant results.
- Results conclusion discussion and recommendations will be given.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic heart failure with mildly reduced ejection fraction (41-49%) and reduced ejection fraction (≤40%)
- •18-70 years
- •Not receiving empagliflozin or any SGLT2 inhibitor
- •Elevated plasma NT-proBNP (≥125 pg/ml)
- •eGFR ≥ 20 ml/min/1.73m2
排除标准
- •Acute Coronary Syndrome (ACS)
- •Pulmonary embolism
- •Myocarditis
- •Valvular heart disease
- •Hypertrophic or restrictive cardiomyopathy
- •Congenital heart disease
- •Pulmonary hypertension
- •Surgical procedures involving the heart
- •Heart contusion
- •Cardioversion, Implantable Cardioverter Defibrillator (ICD) shock
- •Patients receiving digoxin
- •Advanced age (>70years)
- •Ischemic stroke
- •Chronic Obstructive Pulmonary Disease
- •Subarachnoid haemorrhage
- •Severe infection (including pneumonia and sepsis)
- •Renal dysfunction (eGFR <20ml/min/1.73m2)
- •Liver dysfunction (mainly liver cirrhosis with ascites- Child Pugh B & C)
- •Severe burns
- •Paraneoplastic syndrome
- •Severe metabolic and hormone abnormalities (e.g thyrotoxicosis, diabetic ketosis)
研究组 & 干预措施
Heart failure patients with reduced and mildly reduced ejection fraction
Other
- One paired test group described as Heart Failure patients with reduced and mildly reduced ejection fraction are indicated for Empagliflozin.
- Blood samples will be collected as a baseline before Empagliflozin administration to test for N-terminal Pro-B-type Natriuretic Peptide,
- Followed by administration of empagliflozin for 6 months.
- Then retest the N-terminal Pro-B-type Natriuretic Peptide after 6 months.
干预措施: Empagliflozin 10 MG (Drug)
结局指标
主要结局
NT-ProBNP
时间窗: 6 months
Measuring of serum N-terminal Pro-B-type Natriuretic Peptide at baseline and after 6 months
次要结局
- Potassium level mg/dl(6 months)
- Sodium level mg/dl(6 months)
- Hemoglobin level g/dl(6 months)
- Leukocytes count(6 months)
- Serum Creatinine(6 months)
- Ejection Fraction(6 months)
研究者
研究点 (1)
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