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11月16日最近更新: 2020年8月3日

试验速览

暂无简介。

•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 creatinine > 30mg/g or 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

•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 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 unable to give written informed consent.
•12. Participation in another interventional trial in the preceding month
•13. Ability to walk is, in the investigators opinion, clearly limited by joint disease or other locomotor problems or lung diseases rather than by cardiorespiratory fitness

发起方

ACS Biomarker