NCT06097585尚未招募不适用
Effect of Gliflozins on Heart Failure Due to Regurgitant Rheumatic Valve Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 主要终点
- Change of the clinical condition
研究概览
简要总结
The objective of this trial is to detect impact of Gliflozin on patients with heart failure due to reurgitant rheumatic valve disease
详细描述
- Rheumatic heart disease is a chronic sequel of acute rheumatic fever caused by group A β hemolytic Streptococcal pharyngitis and possibly pyoderma, which mimics molecular heart structures so the immune response leads to carditis and valvular heart damage. Damage to valves cause mitral and/or aortic regurgitation, or in long-standing stenosis. Complications of rheumatic heart disease include heart failure, embolic stroke, endocarditis and atrial fibrillation .
- Heart failure (HF) is a progressive syndrome characterised by the inability of the heart to provide adequate blood supply to meet the metabolic demand of different tissues .
- The recent ESC/AHA/ACC guidelines of HF set medications as class 1 for the HF therapy as ACE-I/ ARNI/beta-blocker/MRA/ SGLT2 I as they reduced the risk of cardiovascular death and worsening HF in patients with HFrEF , Unless contraindicated or not tolerated.
- Empagliflozin is an orally available inhibitor sodium glucose co-transporter 2 receptor (SGLT-2), empagliflozin exerts its effect by preventing sodium and glucose reabsorption from proximal convoluted tubules. This leads to increased urinary sodium and glucose excretion, This is associated with a modest osmotic diuresis, blood pressure lowering effect, improvement in arterial stiffness , and decrease in heart rate.
- DAPA-HF trial shows: The primary outcome of cardiovascular death, HF hospitalization, for dapagliflozin vs. placebo, was 16.3% vs 21.2% (p < 0.001).
- EMPA-REG OUTCOME trial shows: The primary outcome, cardiovascular death or HF hospitalization, for empagliflozin vs. placebo, was 19.4% vs. 24.7% ( p < 0.001).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All male or female patients having rheumatic heart disease with either mitral, aortic, tricuspid regurge as a single or combined valvular lesion
- •Patients aged 18 years or older at time of inclusion in the study
- •Patients with HF currently in NYHA class II-IV, or asymptomatic patients with proved mitral regurgitant lesion.
- •Body Mass Index (BMI) < 45 kg/m2
排除标准
- •Advanced stage liver and kidney failure (glomerular filtration rate < 20 mL/min/1.73 m2).
- •Patient with implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or cardiac re-synchronization therapy (CRT) or implanted left ventricular assist device (LVAD)
- •Diagnosis of cardiomyopathy induced by other etiologies rather than rheumatic heart disease eg, ischemia , dilated cardiomyopathy,.....etc within the 12 months prior to Visit 1
- •Known allergy or hypersensitivity to SGLT-2 inhibitors
- •Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- •ongoing hematological diseases and malignancies
研究组 & 干预措施
SGLT2I Group
the case group that will receive SGLT2I in the treatment
干预措施: SGLT2 inhibitor (Drug)
结局指标
主要结局
Change of the clinical condition
时间窗: 6 months up to 1 year
improving or worsening in NYHA class: I- Ordinary physical activity does not cause undue fatigue, dyspnea, or palpitations. II- Ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. III- Comfortable at rest; less than ordinary physical activity causes fatigue, dyspnea, palpitations, or angina. IV- Symptoms occur at rest; any physical activity increases discomfort.
change of the function and regurge
时间窗: 6 months up to 1 year
improving or worsening in echocardiographic parameter : * ejection fraction by simpson methods * severity of regurge by color Doppler and continuous wave Doppler
次要结局
- major adverse cardiovascular event(6 months up to 1 year)
- Glomerular filtration rate affection(6 months up to 1 year)
- urinary tract infection(6 months up to 1 year)
研究者
Ahmed Youssef Dandrawy
residant doctor
Assiut University
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