NL-OMON44913已完成2 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 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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);Or
- •B. At least two of the following:
- •Diabetes Mellitus requiring Hypoglycaemic Pharmacotherapy
- •Receiving pharmacological treatment for Hypertension;• Microalbuminuria, defined as creatinin >30mg/g 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)
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 yours 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/ 1,73 m2, using the MDRD four variable equation
- •6. Serum potassium > 5.0 mmol/L and serum sodium ,125 mmol/l (whether or 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 to 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 (a list is provided in the appendix)
- •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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