Efficacy and Safety of Qishenyiqi Dripping Pills for Treating Chronic Heart Failure With Preserved Ejection Fraction: a Randomized, Double-blind, Basic-treatment-loading, Placebo-controlled, Multicenter Phase Ⅱ Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 225
- 试验地点
- 16
- 主要终点
- 6-Minutes-Walking-Test (6MWT)
研究概览
简要总结
Main objective: To evaluate the efficacy, safety and clinical dose exploration of Qishen Yiqi dripping pills in the treatment of chronic heart failure with preserved ejection fraction.
Exploratory research objective: To explore the changes of endogenous substances in vivo before and after drug administration, to interpret the mechanism of drug action through metabolomics and systems biology methods, and to find potential clinical biomarkers for exploratory subgroup analysis of clinical trials.
详细描述
Main objective: To evaluate the efficacy, safety and clinical dose exploration of Qishen Yiqi dripping pills in the treatment of chronic heart failure with preserved ejection fraction.
Exploratory research objective: To explore the changes of endogenous substances in vivo before and after drug administration, to interpret the mechanism of drug action through metabolomics and systems biology methods, and to find potential clinical biomarkers for exploratory subgroup analysis of clinical trials.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects aged ≥ 18 years
- •Diagnosed as chronic heart failure with preserved ejection fraction according to the Guidelines for Diagnosis and Treatment of Heart Failure in China 2018
- •Have symptoms and/or signs of chronic heart failure at least 30 days before the trial
- •LVEF≥50% according to echocardiography during screening stage
- •BNP > 35 ng/L and/or NT-proBNP > 125 ng/L
- •Cardiac structural changes or diastolic dysfunction according to echocardiography during screening stage, in line with at least one of the following:
- •: LAVI>34ml/m2
- •: average e'(interventricular septum and free wall)<9cm/s
- •Patients with hypertension received a stable dose of antihypertensive therapy for at least 4 weeks and kept their blood pressure at an ideal level for at least 4 weeks
- •Ability to understand the requirements of the study and willingness to provide written informed consent
- •Have no pregnancy program and take effective contraceptive measures voluntarily
- •Abide by the experimental protocol and cooperate with the data collection according to the researcher's judgment
排除标准
- •People with any of the following cardiovascular diseases:
- •Patients with acute decompensated heart failure who need to use quick-acting diuretics, vasodilators, or positive inotropic drugs for treatment, or in the adjustment period of acute decompensated heart failure treatment, and the adjustment time is less than 1 month
- •Clinical evidence of acute coronary syndrome (including myocardial infarction, unstable angina pectoris) within 6 months before screening stage
- •Received prior revascularization (such as PCI, CABG), or implantable cardioverter defibrillator (ICD), or other cardiac/cardiovascular procedures within 3 months before screening stage
- •Received cardiac resynchronization therapy (CRT) within 6 months before screening stage
- •Implantable devices (e.g. ICD, CRT), revascularization (e.g. PCI, CABG), or other cardiac/cardiovascular procedures are expected to be performed during the trial period
- •Patients with acute myocarditis, invasive cardiomyopathy, constrictive pericarditis, cardiac tamponade, hypertrophic obstructive cardiomyopathy, cardiac shock, hemodynamic abnormalities of heart valve disease significantly narrow and/or regurgitation (moderate or above, etc.), Ⅱ degrees above Ⅱ type atrioventricular block placement pacemaker therapy, average QTc > 450 ms or heart rate < 50 times/min
- •Patients with pulmonary artery embolism caused by pulmonary hypertension, chronic obstructive pulmonary disease and other serious pulmonary diseases
- •Hypertension that is difficult to control with medication (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg)
- •Symptomatic hypotension and/or systolic blood pressure <100 mmHg
- •Severe renal insufficiency: eGFR < 30 ml/min/1.73m2
- •ALT and AST > 3 times upper the limit of normal values in local laboratories, and/or total bilirubin > 2 times upper the limit of normal values in local laboratories
- •Serum potassium ≥5.5 mmol/L
- •HbA1c≥9.0%, or fasting blood glucose >13.9 mmol/L
- •Diabetic patients who are using sodium-glucose cotransporter 2 inhibitors and cannot stop using them during the trial, such as dagliredin, entagliredin, and cagliredin
- •The ECG examination indicated the onset of atrial fibrillation during the screening period or previous history of atrial fibrillation within 6 months before screening stage
- •Hemoglobin < 9.0 g/dL
- •Patients have stroke 3 months before the screening period
- •Concomitant mental illness and poor condition control, which affects the signing of informed consent or presentation of adverse events
- •Patients with active malignancies (including those currently under oncology treatment)
- •Unable to conduct the 6-minute walking distance test due to physical impairment or other non-cardiac reasons
- •Women who are pregnant or lactating
- •Allergic constitution, or allergic to the test drug or its ingredients
- •Participate in clinical trials of other drugs within 3 months before screening
- •The researchers did not consider it appropriate to participate in this study
研究组 & 干预措施
Low dose group
The standard basic treatment is given according to the guidelines related to the underlying disease
干预措施: Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time (Drug)
High dose group
The standard basic treatment is given according to the guidelines related to the underlying disease
干预措施: Qishen Yiqi dripping pills 4 bags/time (Drug)
Placebo group
The standard basic treatment is given according to the guidelines related to the underlying disease
干预措施: Qishen Yiqi dripping pills placebo 4 bags/time (Drug)
结局指标
主要结局
6-Minutes-Walking-Test (6MWT)
时间窗: Baseline to weeks 12 and 24
Change from baseline to weeks 12 and 24 in exercise capacity as measured by the 6-Minutes-Walking-Test (6MWT) distance.
次要结局
- NT-proBNP(Baseline to weeks 2,4,8,12,16,20 and 24)
- NYHA classification(Baseline to weeks 2,4,8,12,16,20 and 24)
- LAVI, E/ E ', E 'mean value, LVEF and tricuspid regurgitation velocity(Baseline to weeks 4,12 and 24)
- Hospitalizations for heart failure (first or repeated) and deaths from cardiovascular disease(Week 24)
- Minnesota Living With Heart Failure Questionnaire(MLHFQ) Score(Baseline to weeks 12 and 24)