EUCTR2011-006123-37-IE进行中（未招募）不适用
Impact of Eplerenone on Asymptomatic Left Ventricular Diastolic Dysfunction in Diabetic Patients - Impact of Eplerenone on Asymptomatic Left Ventricular Diastolic Dysfunction in Diabetic Patients
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
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.Over 18 years of age
- •2.Ability to give informed consent
- •3.Type II diabetes mellitus
- •4.Diastolic dysfunction on Doppler-echocardiogram as evidenced by either LAVI >32ml/m2 and/or e' <10cm/s
- •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 30
排除标准
- •1.Age < 18 years at the time of randomisation
- •2.Type I diabetes mellitus
- •3.Administration of eplerenone or spironolactone within 30 days of randomisation
- •4.Patients with serum potassium level <3.5 or >5.0 mmol/L before randomization
- •5.Recent admission for acute cardiovascular event (e.g. ischemia) < 3 months
- •6.Defined history of heart failure, MI, coronary artery bypass grafting, stroke, transient ischemic attack or percutaneous coronary intervention within previous three months or known presence of hemodynamically relevant stenosis of the arteries perfusing the brain
- •7.Significant mitral regurgitation (significant mitral regurgitation will be defined as moderate or severe defined by echo-doppler imaging including extent of doppler signal, extent of proximal isovelocity surface area and pulmonary vein retrograde flow e.g. moderate mitral regurgitation will be regurgitant fraction >30% and/or proximal isovelocity surface area >0.4cm2)
- •8.Documented evidence (ECG) of atrial fibrillation
- •9.Prior documented LVEF <45% or qualitative moderate or severe LV systolic dysfunction
- •10.Revascularisation being actively considered
- •11.Haemodynamically severe valvular heart disease
- •12.Renal dysfunction (GFR < 50 mL/min/1.73m2)
- •i.The estimated GFR (eGFR) will be calculated using the following MDRD equation: eGFR (ml/min/1.73m2) = 186 (serum creatinine mg/dL)1.154 X (age)0.203 X (0.742 if subject is female) X (1.210 if subject is African American).
- •13.Patients with ongoing systemic or hepatic illness
- •14.Patients with severe hepatic insufficiency (Child-Pugh Class C)
- •15.Pregnant women
- •16.HbA1c (IFCC) >69mmol/mol
- •17.Diastolic BP >110 mmHg and a systolic BP >180 mmHg
- •18.Orthostatic hypertension, secondary hypertension or a history of severe or malignant hypertension
- •19.Any clinically significant, abnormal laboratory values that could preclude the patient from safely participating in the study.
- •20.Evidence of significant inflammatory disease, connective tissue disease, hepatic disease, metabolic bone disease which may alter parameters of collagen metabolism
- •21.Hypertrophic, restrictive or constrictive cardiomyopathy
- •22.Severe anaemia (Haemoglobin <8.0 g/dL)
- •23.Subjects with severe hepatic dysfunction defined by AST/ALT/ALP >3 times upper limit of normal
- •24.Recent major surgery (<6 months) (omit trauma)
- •25.Subjects with contraindications to MRI (including but not limited to)
- •a.Hypersensitivity to gadolinium containing contrast agents
- •b.Brain aneurysm clip
- •c.Implanted neural stimulator
- •d.Implanted cardiac pacemaker or defibrillator
- •e.Cochlear implant
- •f.Ocular foreign body (e.g. metal shavings)
- •g.Other implanted medical devices: (e.g. Swan Ganz catheter)
- •h.Implanted insulin pump
- •i.Metal shrapnel or bullet.
- •26.Contraindications to eplerenone therapy:
- •a.Hypersensitivity to eplerenone or any of the excipients.
- •b.Medications interacting with eplerenone therapy taken within 30 days of randomisation:
- •i.Patients receiving potassium-sparing diuretics, potassium-supplements
- •ii.Patients taking strong inhibitors of CYP 3A4 (eg itraconazole, ketoconazole, ritonavir, nelfinavir, erythromycin, clarithromycin, telithromycin and nefazodone).
- •iii.Patients taking strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort) should also be excluded as should patients treated with lithium, ciclosporin and tacrolimus.
- •iv.Patients taking amiodarone, d
研究者
相似试验
进行中（未招募）
1 期
The effects of eplerenone on left ventricular remodelling post-acute myocardial infarction: a double-blind placebo-controlled cardiac MR-based study.EUCTR2004-004399-35-GBorth Glasgow Trust100
已完成
4 期
Effects of Eplerenone on Left Ventricular Remodelling Following Heart AttackMyocardial InfarctionNCT00132093NHS Greater Glasgow and Clyde100
已完成
2 期
Comparative study between Spironolactone vs Eplerenonein patients undergoing revascularization with acute myocardial infarction having LV dysfunctioCTRI/2021/10/037504AIIMS BHUBANESWAR88
招募中
1 期
Evaluation of the effect of Eplerenone in Central serous chorioretinopathy )CSCRCentral serous chorioretinopathyIRCT20220122053792N1Oroumia University of Medical Sciences34
进行中（未招募）
1 期
REMODEL-AMIEUCTR2014-005407-24-CZIKEM