JPRN-jRCTs051200057招募中4 期
Comorbidity Impact Tested by the Drug Treatment of the Patients with Chronic Obstructive Pulmonary Disease and Heart Failure on Cardiovascular Events - COPD-HF
Kitakaze Masafumi0 个研究点目标入组 54 人开始时间: 2020年9月24日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients with CHF and COPD who are over 40 years old at the time of informed consent.
- •2) Patients with CHF and COPD.
- •3) Patients with written consent from the person.
排除标准
- •1) Patients who have already received the drug medical treatment about LAMA or LABA and prohibited concomitant medications for COPD.
- •2) Patients who can not agree to the cessation of smoking.
- •3) Patients with an allergic history of tiotropium or lodaterol.
- •4) Patients with a history of the other severe respiratory diseases (asthma etc.).
- •5) Patients with dysuria of benign prostatic hyperplasia.
- •6) Patients were diagnosed with angle closure glaucoma.
- •7) Patients with acute heart failure (use of intravenous cardiotonic, diuretic and/or antiarrhythmic drugs) or NYHA classification class IV at the time of registration or administration.
- •8) Patients undergoing dose adjustment of digitalis, diuretics, aldosterone antagonists, cardiotonic drugs and antiarrhythmic drugs from 2 weeks before the start of administration.
- •9) Patients with lethal arrhythmia (sustained ventricular tachycardia lasting 30 seconds more or ventricular fibrillation).
- •10) Patients using mechanical circulatory support devices.
- •11) Patients waiting for heart transplant.
- •12) Patients waiting for cardiac surgery.
- •13) Patients within 24 weeks( 6 months) after onset of acute coronary syndrome, within 12 weeks(3 months) afterpercutaneous coronary intervention, or within 24 weeks( 6 months) after open heart surgery.
- •14) Patients who have started cardiac resynchronization therapy within 24 weeks(6 months).
- •15) Patients with severe renal dysfunction (estimated glomerular filtration ratio: eGFR less than 15 mL / min / 1.73m2) or undergoing maintenance hemodialysis or peritoneal dialysis.
- •16) Patients with severe liver dysfunction (T.Bil 10mg / dl or more, AST, ALT 500 IU / L or more, 5 times or more of ALP normal upper limit, PT 40% or less, bleeding tendency, liver failure symptoms such as consciousness disorder (fulminant hepatitis) cirrhosis, liver tumor, Jaundice lasting more than 24 weeks(6 months), Grade A equivalent to Severity classification criteria for side effects of pharmaceuticals 9).
- •17) Patients with decreased white blood cell count (less than 2500 / L) and platelet count (less than 80,000 / L).
- •18) Patients in a serious clinical condition and who are expected to live for < 3 years.
- •19) Patients with possible alcohol or drug abuse.
- •20) Patients who are pregnant or possibly pregnant.
- •21) Women who do not agree with contraception during the study.
- •22) Patients who are breast feeding.
- •23) Patients who have been enrolled in other clinical studies at the same time as this study (excluding observational studies such as registry studies).
- •24) Patients who are judged by the investigator or subinvestigators to not be suitable for participation in the study.
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