Dapagliflozin Effect on Rheumatic Mitral Stenosis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Improvements of Clinical Parameters
研究概览
简要总结
Rheumatic mitral stenosis remains a health problem in developing countries. Progressive fibrosis of the valves and myocardium is the main pathophysiology that plays an important role. Dapagliflozin has various beneficial effects on the heart by reducing fibrosis, reducing inflammation, and improving patient quality of life. However, the role of this therapy is unknown in patients with rheumatic mitral stenosis.
详细描述
This study is an open-label study on Rheumatic Mitral Stenosis patients, carried out at Sebelas Maret University Hospital Sukoharjo, Panti Rahayu Hospital Purwodadi, and Permata Bunda Hospital Purwodadi. Researchers divided 36 Rheumatic Mitral Stenosis patients sequentially into two groups, the first was the dapagliflozin group which would receive dapagliflozin 10 mg once a day and standard treatment. And the second group will only get standard treatment. Each patient will be examined on PICP, MMP-1, MMP-1/TIMP-1 ratio, TGF-β, Net atrioventricular compliance index, NT-pro BNP, and Kansas City Cardiomyopathy Questionnaire on day 1 and one month after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe mitral stenosis by echocardiographic examination of the planimetric method with morphology that supports the etiology of rheumatic
- •Heart failure in functional class II-III
- •Dapagliflozin naive
- •Exception Criteria:
- •Other significant valve diseases
- •Pregnant or breastfeeding
- •Unstable hemodynamic conditions including cardiogenic shock
- •history of mitral valve replacement/repair or mitral balloon valvuloplasty
- •history of hypoglycemia
- •eGFR below 25 mmHg
- •diffuse pulmonary fibrosis
排除标准
- 未提供
研究组 & 干预措施
Dapagliflozin group
Dapagliflozin 10 mg once a day and standard treatment
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Improvements of Clinical Parameters
时间窗: 4 weeks
Kansas City Cardiomyopathy Questionnaire (KCCQ) scores are scaled 0-100 (the higher score indicates a better condition)
Improvements of Biomolecular Parameters
时间窗: 4 weeks
PICP in pg/ml, MMP-1 in pg/ml, MMP-1/TIMP-1 ratio, TGF-β in pg/ml, NT-ProBNP in pg/ml
Improvements of Echocardiography Parameters
时间窗: 4 weeks
Net atrioventricular compliance in mL/mmHG, mitral valve gradient in mmHg and mPAP in mmHg
次要结局
- Major Adverse Cardiac Events(4 weeks)
研究者
An Aldia Asrial
An Aldia Asrial, MD, FIHA (Principal investigator)
Universitas Sebelas Maret