EUCTR2011-001674-25-ES进行中（未招募）1 期
Evaluation of the efficacy of sildenafil on the functional capacity of patients with heart failure with preserved ejection fraction. A randomized, double blind, parallel group and placebo-controlled clinical trial. - SILICCO
Francisco J. González Vílchez0 个研究点目标入组 100 人开始时间: 2012年3月28日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
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 > 18 years.
- •2. Previous diagnosis of heart failure by any of the following:
- •- Criteria of Framingham.
- •- Hospitalization for decompensated heart failure.
- •- Long-term treatment with a loop diuretic and chronic diastolic dysfunction (left atrial enlargement by echocardiography).
- •3. Current symptoms with functional class (NYHA) II-IV.
- •4. Left ventricular ejection fraction > 50% by echocardiography whinthin the previous 3 months before study entry.
- •5. Receiving stable medical therapy in the 30 days before study entry, as determined by no addition or removal of angiotensin converting enzyme inhibitor (ACE), angiotensin receptor blocker (ARB), beta-blockers, or calcium channel blockers (CCB) and no change in dosage of ACE, ARBs, beta-blockers, or CCBs of more than 100%.
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 70
排除标准
- •1. Has a non-cardiac condition that prevents the subject from exercise testing or from walking in a hallway.
- •2. Non-cardiac life expectancy < 1 year.
- •3. Current or anticipated future need for nitrate therapy.
- •4. Any valvular, pericardial o cardiomyopathy with specific therapy requirements.
- •5. Acute coronary syndrome o coronary revascularization in the previous 6 months or expected need of coronary revascularization in the year after study entry.
- •6. Any non-cardiac condition known to be associated with dyspnea (morbid obesity [Body mass index > 35 Kg/m2] or lung disease requiring oxygen or esteroids or FEV1 < 50% predicted or Epworth Sleepiness Scale > 20).
- •7. Resting blood pressure < 110 / 40 mmHg or > 180 /100.
- •8. Resting heart rate > 100 bpm.
- •9. History of ejection fraction < 50%.
- •10. Hb < 10 g/dL, severe renal disease (estimated glomerular filtration rate < 20 ml/min/1.73m2 g) or severe hepatic disease (aspartate aminotransferase level > 3 times the normal limit, alkaline phosphatase or bilirubin > 2 times the normal limit).
- •11. Pregnant or not using an effective form of contraception.
- •12. Taking nitrates, alpha antagonists, cytochrome P450 3A4 inhibitors/inducers, nicorandil, ranolazine or molsidain.
- •13. Retinitis pigmentosa, previous diagnosis of nonischemic optic neuropathy, untreated proliferative retinopathy, or unexplained visual disturbance.
- •14. Sickle cell anemia, multiple myeloma, leukemia, or penile deformities that increase the risk for priapism (e.g., angulation, cavernosal fibrosis, Peyronie's disease).
- •15. Severe cardiac ischemia in scintigraphy or echocardiography.
- •16. Primary pulmonary arteriopathy.
- •17. Inability or unwillingness of individual to give written informed consent.
- •18. Participation in a clinical trial within the 6 months prior to the present study.
- •19. History of allergy or intolerance to Sildenafil or other 5-Phosphodiesterase inhibitor.
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