EUCTR2015-000413-48-IE进行中（未招募）1 期
Bioprofiling response to mineralocorticoid receptor antagonists for the prevention of heart failure. A proof of concept clinical trial within the EU FP 7 HOMAGE” programme « Heart OMics in AGing - HOMAGE
ACS Biomarker0 个研究点目标入组 800 人开始时间: 2015年5月8日最近更新:
适应症
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
- 800
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 will be obtained prior to any study procedure;
- •2. Age >60years
- •3. Clinical risk factors for developing heart failure, either:
- •Coronary artery disease (h/o myocardial infarction, angioplasty or coronary artery bypass)
- •B. At least two of the following:
- •Diabetes Mellitus requiring Hypoglycaemic Pharmacotherapy
- •Receiving pharmacological treatment for Hypertension
- •Microalbuminuria (defined as albumin/creatinine ratio > 3mg/mmol whatever the gender)
- •Abnormal ECG (left ventricular hypertrophy, QRS >120msec,
- •abnormal Q-waves)
- •4. Biological risk: NT-pro-BNP values between 125 and 1,000 ng/L or BNP values between 35 and 280 pg/ml (consistent with ESC guidelines indicating risk of HF but helping to rule out prevalent HF or atrial fibrillation which are associated with marked increases in NT-proBNP/BNP and should be investigated)
- •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 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 640
排除标准
- •1. Recent wound healing/inflammation:
- •Surgical procedure, coronary, cerebral or peripheral vascular events or infection in the prior 3 months
- •Cancer (life limiting or less than 2 years in remission)
- •Autoimmune disease
- •Hepatic Disease
- •2. Pre-existing diagnosis of clinical HF
- •3. Moderate/severe LV systolic ventricular dysfunction, i.e. LVEF <45%
- •4. Moderate or severe valve disease (investigators opinion)
- •5. Corrected eGFR< 30ml/min /1.73m2, using the MDRD four-variable equation
- •6. Serum potassium >5.0 mmol/L and serum sodium <125 mmol/L (whether ot not associated with hepatic cirrhosis)
- •7. Treatment with an MRA or a loop diuretic (furosemide, bumetanide, ethacrynic acid or torasemide) in the previous three months
- •8. Potassium supplements or potassium-sparing diuretic at time of enrolment.
- •9. Atrial fibrillation within one month prior to inclusion (AF lasting <60 seconds on ambulatory ECG monitoring is permitted)
- •10. History of hypersensitivity to spironolactone or any of its excipients.
- •11. Patients who require treatment with prohibited medication according to the summary of product characteristics with the exception of ACE inhibitors or angiotensin receptor blockers – although not their combination
- •12. Patients unable to give written informed consent.
- •13. Participation in another interventional trial in the preceding month
- •14. Ability to walk is, in the investigators opinion, clearly limited by joint disease or other locomotor problems or lung disease rather than by cardiorespiratory fitness
研究者
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