EUCTR2013-001312-30-IT进行中（未招募）不适用
ong term effects of selective beta1-adrenoceptor blockade with bisoprolol on hospital readmissions of elderly patients with coexisting heart failure and chronic obstructive pulmonary disease: a multicentre randomized controlled trial
niversità di Napoli Federico II0 个研究点开始时间: 2013年7月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Age > 75 years
- •2. Diagnosis of HF according to AHA/ACC (J Am Coll
- •Cardiol 2006;47:1503-1505) made at least 3 months
- •previously. At enrollment, patients must be on stage B-C or
- •NYHA II-III.
- •3. Diagnosis of COPD according to the ATS/ERS criteria
- •(Eur Respir J. 2004 ;23:932-46), made at least 3 months
- •previously, in GOLD stage II-III.
- •All the enrolled patients must be clinically stable during
- •the preceding 3 weeks and in standard therapeutic regimen,
- •according to the guidelines for HF and COPD, before
- •being randomized either to treatment or to placebo groups.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 823
排除标准
- •2. Inability to perform spirometry.
- •3. Any type of neoplasm.
- •4. Any non-neoplastic disease limiting life expectance to
- •less than one year.
- •5. Cognitive or sensorial impairment preventing all the
- •study planned evaluations
- •6. Critical social and enviromental status preventing an
- •adequate drug compliance.
- •7. Contraindications to ß-blocker therapy
- •8. Previous evidence of adverse drug reactions to
- •ß-blockers
- •9. Decompensated liver cirrhosis, renal failure (serum
- •creatinine >3 mg/dl).
- •10. Decompensated diabetes.
- •11. Acute myocardial infarction and cerebrovascular events
- •occurred in the last 3 months
- •12. Logistic issues preventing follow-up completion.
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