Metoprolol in Patients With Heart Failure With Reduced Ejection Fraction and Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 311
- 主要终点
- Composite endpoints (all-cause death and rehospitalization)
研究概览
简要总结
The goal of the clinical trial was to see if Metoprolol was effective in treating patients with heart failure and chronic obstructive pulmonary disease. It will also learn about the safety of Metoprolol. The main questions it aims to answer are:
Did Metoprolol reduce the frequency of all-cause deaths and re-hospitalizations in subjects? What medical problems do participants experience after taking Metoprolol? The researchers will compare different doses of Metoprolol to see the best dose for Metoprolol.
Participants will:
Take Metoprolol 23.75mg/ day or the maximum tolerable dose of Metoprolol daily for 24 months.
Regular outpatient follow-up visits to the research center. Their symptoms and Metoprolol dosage were recorded.
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
- •A definite diagnosis of HFrEF (LVEF≤40%), NYHA II to IV , and the disease is due to ischemic heart disease or dilated cardiomyopathy;
- •A definite diagnosis of COPD with moderate or higher airflow limitation (FEV1/FVC < 0.7 and FEV1 < 80% of the expected value);
- •Age ≥18 years old;
- •Informed consent has been obtained and signed.
排除标准
- •the dose of Metoprolol before enrollment was more than 23.75mg/d;
- •Resting heart rate < 50 beats/min;
- •Second or third degree atrioventricular block;
- •Atrial fibrillation;
- •Sick sinus syndrome;
- •Systolic blood pressure < 90mmHg;
- •Acute attack of bronchial asthma;
- •Liver insufficiency (serum transaminase > 3 times the normal value);
- •Renal insufficiency (eGFR < 30ml/min/1.73m2, or serum creatinine > 2.5mg/dL[> 221μmol/L]);
- •Patients with serious physical diseases, such as cancer;
- •Patients who have a history of allergy to the investigational drug or its ingredients;
- •Participating in other clinical investigators;
- •During the study period, Patients cannot live in the selected center for a long time, which is not conducive to the follow-up;
- •Patients with disability, mobility disability, intellectual disability and other factors that may prevent normal participation in the study and follow-up, and their frailty was assessed by the FRAIL frailty screening scale; Intellectual mental status was assessed by the Mini-Mental State Examination (MMSE).
- •Poor adherence or other reasons considered by the researchers to be unsuitable for the clinical trial.
研究组 & 干预措施
Experimental Group
The experimental group received the maximum tolerable dose of Metoprolol.
干预措施: Different doses of Metoprolol. (Drug)
Control Group
The control group received 23.75mg/d of Metoprolol.
干预措施: Different doses of Metoprolol. (Drug)
结局指标
主要结局
Composite endpoints (all-cause death and rehospitalization)
时间窗: From enrollment to the end of treatment at 24 months.
Rehospitalization included readmission for heart failure and/or COPD.
次要结局
- All-cause death(From enrollment to the end of treatment at 24 months.)
- Cardiovascular death(From enrollment to the end of treatment at 24 months.)
- Rehospitalization for heart failure(From enrollment to the end of treatment at 24 months.)
- Re-hospitalization for COPD(From enrollment to the end of treatment at 24 months.)