研究疾病:
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房颤心衰
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研究疾病代码:
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Target disease:
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atrial fibrillation and chronic heart failure
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Target disease code:
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研究类型:
Study type:
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干预性研究
Interventional study
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研究设计:
Study design:
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随机平行对照
randomized controlled trial(parallel group design)
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研究所处阶段:
Study phase:
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探索性研究/预试验
Pilot clinical trial
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研究目的:
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房颤,是临床最常见的心律失常之一,心力衰竭是多种心脏疾病发展的最终阶段,二者相互促进,相互影响,导致恶性循环。研究表明,心衰患者易合并存在吸气肌无力,可导致患者的运动耐量及生活质量的进一步下降,出现预后恶化。六字诀呼吸法,是一种以静为主,注重养生的传统康复训练方法,研究显示,六字诀可以显著改善呼吸肌功能。本研究首先通过回顾性研究,拟入纳入房颤伴慢性心力衰竭患者,观察其发病规律、中医证型分布情况及潜在的危险因素,以中医治未病理念为指导,构建房颤-心衰临床预测模型;其二采用随机对照研究,对中医心脏康复-六字诀呼吸吐纳方案的治疗房颤伴慢性心衰患者进行有效性及安全性评估,观察不同组分心功能影响差异,并同时关注中医证候的演变,为丰富房颤伴慢性心力衰竭患者中医康复方案提供较为可靠的科学依据,进一步充实中医心脏康复干预策略。
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Objectives of Study:
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Atrial fibrillation is one of the most common arrhythmias in clinic. Heart failure is the final stage of the development of a variety of heart diseases. The two promote and affect each other, leading to a vicious circle. Studies have shown that patients with heart failure are prone to be associated with inspiratory muscle weakness, which can lead to the further decline of exercise tolerance and quality of life, and the deterioration of prognosis. The six character formula breathing method is a traditional rehabilitation training method focusing on calmness and health preservation. Research shows that the six character formula can significantly improve the respiratory muscle function. Firstly, through a retrospective study, the patients with atrial fibrillation and chronic heart failure were included in this study to observe their pathogenesis, the distribution of TCM Syndrome Types and potential risk factors, and to construct a clinical prediction model of atrial fibrillation and heart failure under the guidance of the concept of prevention of disease in traditional Chinese Medicine; Secondly, a randomized controlled study was conducted to evaluate the effectiveness and safety of the traditional Chinese medicine heart rehabilitation six character formula breathing and breathing regimen in the treatment of patients with atrial fibrillation and chronic heart failure, to observe the differences in the effects of different groups on distraction function, and to pay attention to the evolution of traditional Chinese medicine syndromes, so as to provide a more reliable scientific basis for enriching the traditional Chinese medicine rehabilitation program for patients with atrial fibrillation and chronic heart failure, and to further enrich the intervention strategy of traditional Chinese medicine heart rehabilitation.
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药物成份或治疗方案详述:
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本设计方案采用随机对照研究的方法,分成中西医组与中医康复+中西医组,对于中西医组,采用常规临床治疗。中医康复+中西医组采用六字诀呼吸吐纳法+常规中西医治疗,随访1年,观察指标为患者NT-proBNP、6分钟步行试验、心脏超声指标、动态血压、动态心电图、生化指标、主要心血管事件、生活质量、安全性指标及不良事件发生情况。
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Description for medicine or protocol of treatment in detail:
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This design adopts the method of randomized control study, which is divided into traditional Chinese and Western medicine group and traditional Chinese medicine rehabilitation + traditional Chinese and Western medicine group. For the traditional Chinese and Western medicine group, routine clinical treatment is adopted. The TCM rehabilitation + traditional Chinese and Western medicine group was treated with the six character formula breathing and breathing method + routine traditional Chinese and Western medicine. The patients were followed up for 1 year. The observation indicators were NT proBNP, 6-minute walking test, cardiac ultrasound indicators, ambulatory blood pressure, ambulatory electrocardiogram, biochemical indicators, major cardiovascular events, quality of life, safety indicators and adverse events.
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纳入标准:
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1. 年龄 30-80 岁,性别不限;
2. 符合诊断标准;
3. 有良好的依从性;
4. 签署知情同意书。
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Inclusion criteria
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1. Age 30-80 years old, gender unlimited;
2. Meet the diagnostic criteria;
3. Good compliance;
4. Sign informed consent.
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排除标准:
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1. 排除其他原发性疾病导致(慢性肾脏病、慢性肝病、甲状腺功能减退症)的血糖、血脂、血压的异常;
2. 合并有严重的心脑血管疾病的,如急性心力衰竭、严重高血压、脑出血等;
3. 合并严重肝功能异常者(ALT或AST达到正常值上限3倍以上)、内分泌疾病、恶性肿瘤以及自身免疫性疾病者;
4. 妊娠、准备妊娠或哺乳期女性;
5. 过敏体质及对本研究用药组成成分过敏者;
6. 正在参加其它临床试验或参加过其它药物临床试验结束未超过1个月者。
7. 瓣膜性房颤患者。
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Exclusion criteria:
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1. Exclude the abnormality of blood glucose, blood lipid and blood pressure caused by other primary diseases (chronic kidney disease, chronic liver disease and hypothyroidism);
2. Complicated with serious cardiovascular and cerebrovascular diseases, such as acute heart failure, severe hypertension, cerebral hemorrhage, etc;
3. Patients with severe liver dysfunction (ALT or ast reaching more than 3 times the upper limit of normal value), endocrine diseases, malignant tumors and autoimmune diseases;
4. Pregnant, pregnant or lactating women;
5. Allergic constitution and allergic to the components of this study;
6. Those who are participating in other clinical trials or have participated in other drug clinical trials for less than 1 month.
7. Patients with valvular atrial fibrillation.
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研究实施时间:
Study execute time:
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从From
2021-10-31
至To
2024-09-01
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征募观察对象时间:
Recruiting time:
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从From
2022-12-01
至To
2024-09-01
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