研究疾病:
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慢性心衰
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研究疾病代码:
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Target disease:
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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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评估具有温阳活血利水作用的心衰贴改善射血分数降低心衰的临床疗效
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Objectives of Study:
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To evaluate the clinical effect of heart failure patch with the function of warming Yang, activating blood and promoting water on improving ejection fraction and reducing heart failure
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药物成份或治疗方案详述:
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所有受试者继续给予主治医师制定的规范抗心衰治疗方案,包括利尿剂、血管紧张素转换酶抑制剂(ACEI)/血管紧张素 II 受体拮抗剂(ARB)/血管紧张素受体脑啡肽酶抑制剂(ARNI)、β 受体阻滞剂、醛固酮受体拮抗剂等,基础治疗方案在试验期间不更改用药种类及剂量。纳入的受试者随机分为试验组和对照组。停用一切中药、中成药及中医外治法,经过 3-7 天导入期后进入治疗期,治疗期间不加用中药治疗,随机分为试验组和对照组。
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Description for medicine or protocol of treatment in detail:
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All subjects continued to receive the standard anti-heart failure treatment regimen formulated by the attending physician, including diuretics, angiotensin-converting enzyme inhibitors (ACEI)/ angiotensin II receptor blockers (ARB)/ angiotensin receptor neprilysin inhibitors (ARNI), β-blockers, aldosterone receptor antagonists, etc. The type and dose of the underlying regimen were not changed during the trial. The included subjects were randomly divided into experimental group and control group. All Chinese medicine, Chinese patent medicine and external treatment of Chinese medicine were stopped, and after 3-7 days of run-in period, the patients entered the treatment period, and no Chinese medicine treatment was added during the treatment period. The patients were randomly divided into experimental group and control group.
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纳入标准:
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(1)年龄在 18~80 岁之间;
(2)符合慢性心力衰竭稳定期诊断标准;
(3)纽约心脏病协会(NYHA)心功能分级为 II~III 级;
(4)射血分数降低(LVEF<40%)的患者;
(5)中医辨证为阳气亏虚血瘀证兼痰饮者;
(6)Lee 氏心衰积分≥6 分;
(7)受试者充分知情同意,自愿参加本研究,由本人签署知情同意书。
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Inclusion criteria
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(1) aged between 18 and 80 years old;
(2) meet the diagnostic criteria for stable chronic heart failure;
(3) New York Heart Association (NYHA) functional class II-III;
(4) patients with reduced ejection fraction (LVEF < 40%);
(5) The syndrome of Yang qi deficiency and blood stasis combined with phlegm and drink;
(6) Lee's heart failure score ≥6;
(7) The subjects had fully informed consent to participate in this study voluntarily, and signed the informed consent form by themselves.
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排除标准:
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(1)由于肾、肝等重要脏器功能衰竭导致心力衰竭者;
(2)重度心力衰竭、心功能属 IV 级者不宜纳入试验病例;
(3)存在各种恶性肿瘤或可疑恶性肿瘤者;
(4)6 个月内血栓拴塞性疾病病史;
(5)患有明显肝肾疾患或 ALT、AST 高于 ULN 1.5 倍,肌酐、尿素氮高于 ULN 1.5 倍;
(6)严重的精神病、造血系统疾病等重大疾病患者;
(7)处于孕期、哺乳期或妊娠检查阳性的女性受试者或一定时间内有生育计划;
(8)皮肤有红肿、破溃或皮肤病患者;
(9)近三个月内参加过或正在参加其它临床研究者;
(10)对研究药物可疑或明确过敏者;
(11)凡能增加死亡率的因素:如心源性休克、严重室性心律失常、完全性房室传导阻滞、梗阻型心肌病、未修补的瓣膜病、缩窄性心包炎、心包填塞、肺栓塞,有明显感染者,以及没有控制的高血压、急性心肌炎、合并急性冠脉综合征、近期需要器械治疗的慢性心衰患者等,均不宜入选。
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Exclusion criteria:
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(1) Heart failure due to kidney, liver and other important organ failure;
(2) Patients with severe heart failure or grade IV heart function were not included in the study.
(3) presence of various malignant tumors or suspicious malignant tumors;
(4) history of thrombotic disease within 6 months;
(5) patients with obvious liver and kidney diseases or ALT and AST higher than ULN 1.5 times, creatinine and urea nitrogen higher than ULN 1.5 times;
(6) patients with severe mental disorders, hematopoietic system diseases and other major diseases;
(7) women who are pregnant, lactating or have a positive pregnancy test, or have plans to give birth within a certain period of time;
(8) patients with redness, swelling, ulceration or skin diseases;
(9) have participated or are participating in other clinical investigators within the past three months;
(10) suspected or definite allergy to study drugs;
(11) Factors that increase mortality: Patients with cardiogenic shock, severe ventricular arrhythmia, complete atrioventricular block, obstructive cardiomyopathy, unpatched valvular disease, constrictive pericarditis, pericardial tamponade, pulmonary embolism, obvious infection, uncontrolled hypertension, acute myocarditis, acute coronary syndrome, and chronic heart failure requiring device therapy were excluded.
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研究实施时间:
Study execute time:
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从From
2023-01-01
至To
2025-12-31
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征募观察对象时间:
Recruiting time:
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从From
2023-08-31
至To
2025-09-30
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