The Relationship Between XinKang-I and Chronic Heart Failure: Protocol for a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- oxygen consumption volume of anaerobic threshold (VO2AT, ml)
研究概览
简要总结
Background: Heart failure is the severe and terminal stage of various heart diseases, which is characterized by high morbidity, mortality and readmission. There are few studies on the relationship between XinKang-I(XK-I) and chronic heart failure.
Objective: To explore the relationship between XK-I and chronic heart failure. Methods/design: The trial is a single-center, single-blind, randomized study (1:1). It will recruit 110 patients with chronic heart failure who syndrome of qi deficiency yang deficiency and blood stasis. The intervention group will receive not only Western medicine, but also XK-I. The primary end points will be the changes in oxygen consumption volume of anaerobic threshold (VO2AT), maximum oxygen volume uptake (VO2max), and 6-minute walking distance after 8 weeks of treatment. Both groups will receive 8 weeks of treatment.
Ethics and dissemination: Ethical approval was granted by Ethics Committee of Dongguan TCM Hospital. Results will be disseminated via peer-reviewed publications and presentations at international conferences.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of CHF or clinical findings of CHF for more than 3 months. CHF was diagnosed in accordance with the European Society of Cardiology's 2021 Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure.
- •Patients ranged in age from 18 to
- •Cardiac function was graded at grade II-IV (New York Heart Association functional class).
- •Patients who had not used traditional Chinese medicine for treating heart failure within 1 week before enrollment;
- •Written informed consent will be obtained.
排除标准
- •acute cardiac insufficiency, acute myocarditis, severe valvular heart disease, malignant arrhythmia, obstructive cardiomyopathy, pericardial tamponade, constrictive pericarditis or acute coronary syndrome
- •severe lung, liver or kidney dysfunction
- •nervous and hematopoietic system
- •malignant tumors
- •hemodynamic nstability
- •pulmonary embolism
- •severe infection
- •pregnant or lactating
- •refusal to provide written informed consent for this study
研究组 & 干预措施
intervention group
The intervention group will receive not only Western medicine, but also XK-I. The therapeutic drugs used in the control group will be according to the European Society of Cardiology's 2021 guidelines for the diagnosis and treatment of acute and chronic heart failure.
干预措施: Traditional Chinese medicine prescription：XinKang-I (Drug)
结局指标
主要结局
oxygen consumption volume of anaerobic threshold (VO2AT, ml)
时间窗: 8 weeks
Cardiac function
The changes in 6-minute walking distance(distance, meter).
时间窗: 8 weeks
Cardiac function
maximum oxygen volume uptake (VO2max, ml/min) in cardiopulmonary function test
时间窗: 8 weeks
Cardiac function
次要结局
未报告次要终点
研究者
Jianfeng Ye
Head of Cardiology
Dongguan Hospital of Traditional Chinese Medicine