NCT02812862撤回4 期
Cardiac Effects of Spiolto®/Respimat® in Patients With Congestive Heart Failure and COPD
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- To examine the change in Residual Volume (RV) V0-V2
研究概览
简要总结
The aim of this study is to evaluate the pulmonary and cardiac effects of the LABA / LAMA combination Tiotropium / Olodaterol therapy in patients suffering from both congestive heart failure and chronic obstructive pulmonary disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Adults who are contractually capable and mentally able to understand and follow the instructions of the study personnel
- •Symptomatic with regard to dyspnea (NYHA II-III, mMRC Dyspnea score > 1)
- •Diagnosis of COPD (FEV1/FVC ratio <70%, FEV1 < 80%)
- •Patients with hyperinflation at rest defined as Residual Volume (RV) > 135 % predicted
- •Diagnosis of moderate symptomatic ischaemic Congestive heart failure (LVEF > 35 -45%)
- •Stability of CHF during the preceding 3 months (no hospitalization due to CHF, stable CHF medication)
- •Male or female aged > 18 years
- •Written informed consent prior to study participation
- •The subject is willing and able to follow the procedures outlined in the protocol
排除标准
- •Lack of informed consent
- •Pregnant and lactating females
- •Acute moderate-severe exacerbation of COPD, acute respiratory failure (pH < 7,35 and/ or respiratory rate > 30/min within 3 months prior to inclusion)
- •Unstable heart failure or planned change in medication (hospitalization due to CHF within 3 months prior to inclusion), any angina pectoris
- •Not symptomatic
- •Patient has been committed to an institution by legal or regulatory order
- •Participation in a parallel interventional clinical trial
- •Any COPD maintenance therapy before start of randomization
- •History or diagnosis of Asthma
- •LVEF <35 % or ICD or pacemaker
- •Myocardial infarction 6 months prior inclusion
- •History of life-threatening arrhythmias (e.g. NSVT or ventricular tachycardia, aFib, AV-Block, pacemaker treatment etc.)
- •History of diagnosis of Thyrotoxicosis
- •Chronic kidney disease with an crea-clearance ≤30 ml/min
- •History of significant alcohol or drug abuse, as judged by the Investigator
- •Fibrotic lung disease (e.g. IPF, ILD)
- •Contraindications for MRT (e.g. pacemaker, defibrillator, ferromagnetic metal implants, tattoos, claustrophobia, etc. according to MRI checklist used in the clinical routine)
研究组 & 干预措施
Treatment group
Experimental
20 male and female patients suffering from chronic heart failure and chronic obstructive pulmonary disease.
Patients will be treated with Spiolto® Respimat® (the LABA/ LAMA combination)
干预措施: Spiolto® Respimat® (Tiotropium / Olodaterol) (Drug)
结局指标
主要结局
To examine the change in Residual Volume (RV) V0-V2
时间窗: 24 months
次要结局
- To examine the change in trough FEV1(24 months)
研究者
研究点 (1)
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