Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- measurement of change in membrane diffusion (Dm)
研究概览
简要总结
The purposes of this study are:
- To confirm safety of Indacaterol in stable Heart Failure.
- To determine whether beta 2 alveolar receptor stimulation by Indacaterol is able to ameliorate lung diffusion in heart Failure patients treated with beta blockers.
- To compare the effects of Indacaterol in patients treated with a non-selective beta blocker (Carvedilol) and a beta 1-selective beta blocker (Bisoprolol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 and female adults aged ≥ 18 years who have signed an Informed Consent Form.
- •Patients with light chronic obstructive pulmonary disease never treated with bronchodilator drugs
- •Co-operative patients
- •Patients with a clinical diagnosis of chronic heart failure (HF)
- •chronic myeloproliferative disorder with ejection fraction < 40% with B Blockers therapy since at least 2 months. Optimized and individually tailored drug treatment including B blocker (Carvedilol or bisoprolol)
- •Capability of performing Cardiopulmonary Exercise Test and lung diffusion test
排除标准
- •History or clinical documentation of:
- •pulmonary embolism
- •primary valvular heart disease
- •pericardial disease
- •severe obstructive lung disease
- •significant peripheral vascular disease
- •exercise-induced angina, st changes, or severe arrhythmias.
- •Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a history of blood glucose levels consistently outside the normal range or HbA1c > 8.0 % of total hemoglobin measured.
- •Use of bronchodilators.
- •Patients with a history (or family history) of long QT syndrome or whose corrected QT interval interval (Fridericia) measured at Visit 2 is prolonged: >450 ms (males) or >470 ms (females) as assessed by the central electrocardiogram (ECG) interpretation.
研究组 & 干预措施
Indacaterol
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
干预措施: Indacaterol (Drug)
Placebo
Inside this arm we also compare the effect of Carvedilol to the effect of Bisoprolol
干预措施: Placebo (Drug)
结局指标
主要结局
measurement of change in membrane diffusion (Dm)
时间窗: day 0, 60, 74, 134
comparison of change in mambrane diffusion (Dm) after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
measurement of change in capillary volume (Vc)
时间窗: day 0, 60, 74, 134
comparison of change in Vc after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
measurement of change in lung diffusion of carbon monoxide (CO).
时间窗: day 0, 60, 74, 134
comparison of change in lung diffusion of carbon monoxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
measurement of change in lung diffusion of NO (Nitric Oxide)
时间窗: day 0, 60, 74, 134
Measurement of change in lung diffusion of nitric oxide after treatment placebo/indacaterol between the carvedilol and bisoprolol groups.
次要结局
未报告次要终点
研究者
Piergiuseppe Agostoni
PhD
Centro Cardiologico Monzino