EUCTR2005-003351-12-ES进行中（未招募）不适用
The effect of eplerenone versus placebo on cardiovascular mortality and heart failure hospitalization in subjects with NYHA Class II Chronic Systolic Heart FailureEfecto de eplerenona versus placebo sobre la mortalidad cardiovascular y la hospitalización por insuficiencia cardiaca en sujetos con insuficiencia cardiaca sistólica crónica, clasificación NYHA II
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- PFIZER
- 入组人数
- 2,584
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. Written informed consent obtained prior to the initiation of any study procedures
- •2. Male or female subjects, =60 years of age at the time informed consent is obtained
- •3. Chronic systolic heart failure (HF) of either ischemic or non-ischemic etiology:
- •a) Duration: at least 4 weeks
- •b) Left ventricular ejection fraction (LVEF): =30% by echocardiography, contrast
- •ventriculography or nuclear imaging
- •c) Functional Capacity: Usually NYHA II (in the investigator’s opinion)
- •d) Treatments (for ACE inhibitors, ARBs and b-blockers, optimal target or maximal
- •tolerated dose [see Appendix 1 of the protocol] unless contraindicated):
- •i) Angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor
- •blockers (ARBs)
- •ii) b-blocker
- •iii) Diuretic, if clinically indicated to reduce fluid retention
- •4. Serum potassium (K+) level =5.0mmol/L
- •5. Estimated glomerular filtration rate (eGFR) >30 ml/min/1.73m2 (see Appendix 2 of the protocol)
- •6. Randomization must occur no later than 90 days from the date of admission for index cardiovascular (CV) hospitalization. (If clinically stable, the subject may be randomized during this index cardiovascular (CV) hospitalization.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •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
排除标准
- •1. Patients with severe chronic systolic heart failure, defined as patients who demonstrate symptoms usually at rest despite optimal medical therapy
- •2. Patients with a myocardial infarction complicated by left ventricular systolic dysfunction and clinical heart failure within 30 days prior to randomization
- •3. Patients, who in the opinion of the investigator, require treatment with eplerenone or spironolactone
- •4. Patients, who in the opinion of the investigator, require treatment with potassium-sparing diuretics or potassium supplements
- •5. History of hypersensitivity to eplerenone or spironolactone
- •6. Evidence of cardiogenic shock
- •7. Intra-aortic balloon pump or other mechanical assist device
- •8. Patients awaiting cardiac transplantation
- •9. Serum potassium > 5.0 mmol/L within 24 hours prior to randomization
- •10. Estimated glomerular filtration rate (eGFR) =30 ml/min/1.73m2 within 24 hours prior to randomization (see Appendix 2 of the protocol)
- •11. Concomitant use of potent cytochrome p450 3A4 (CYP3A4) inhibitors, such as but not limited to:
- •a. Ketoconazole
- •b. Itraconazole
- •c. Nefazodone
- •d. Troleandomycin
- •e. Clarithromycin
- •f. Ritonavir
- •g. Nelfinavir
- •12. Patients with significant hepatic disease, defined as follows:
- •h. Aspartate aminotransferase (AST) >3 times the upper limit of normal
- •i. Alanine aminotransferase (ALT) >3 times the upper limits of normal
- •j. Known positive serology for viral hepatitis
- •13. Patients status-post gastric bypass surgery, partial gastrectomy or other surgery of the gastrointestinal tract that may interfere with the absorption of eplerenone
研究者
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