NCT06401343招募中4 期
Sodium-dependent Glucose Transporters 2 Inhibitor in Nonobstructive Hypertrophic Cardiomyoapthy Patients With Heart Failure With Preserved Ejection Fraction: a Prospective, Multi-center,Open-lable,Randomized Controlled Trial
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2022年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- VO2max on cardiopulmonary exercise tesing
研究概览
简要总结
This study aims to evaluate the impact of Sodium-dependent glucose transporters 2 inhibitor Empagliflozin on the exercise capacity,symptoms of heart failure, cardiac function, myocardial remodeling and quality of life of nonobstructive HCM patients with HFpEF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of nonobstructive hypertrophic cardiomyopathy;
- •At least 18 years old;
- •Elevated NT-proBNP >300 pg/ml for patients without atrial fibrillation (AF), or >900 pg/ml for patients with AF at Visit 1;
- •NYHA II-IV
- •Capable of performing cardiopulmonary exercise test with an RER≥1.0
- •Signed and dated written informed consent and willing to return for clinical follow-up.
排除标准
- •Under-went septal reduction therapy within 3 months before screening;
- •Acute decompensation heart failure within 3 months before screening;
- •Symptomatic low BP or SBP<100mmHg;
- •eGFR<30ml/min/1.73m2
- •LVOTG ≥30mmHg at rest or under provocation;
- •Renal insufficiency with eGFR<50mL/min/1.73m2
- •ICD implantation or CRT planned within 3 months;
- •Women who are pregnant, or who plan to become pregnant while in the trial;
- •Currently enrolled in another investigational device or drug trial;
- •Combining any other clinical condition with a life expectancy less than 1 year.
研究组 & 干预措施
Study group
Experimental
Use of Empagliflozin+guideline directed medical treatment of HCM
干预措施: Empagliflozin 10 MG (Drug)
结局指标
主要结局
VO2max on cardiopulmonary exercise tesing
时间窗: 12 months
次要结局
- NT-ProBNP(12 months)
- HCMSQ-(SoB)(12 months)
- NYHA heart failure classification(12 months)
- E/A(12 months)
- KCCQ-CSS(12 months)
- Peak tricuspid regurgitation velocity(12 months)
- Left atrium volume index , LAVI(12 months)
- Left Ventricular Mass index, LVMI(12 months)
- E/e'(12 months)
研究者
Lianming Kang
Dr. Lianming Kang
China National Center for Cardiovascular Diseases
研究点 (1)
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