EUCTR2010-021664-16-IE进行中（未招募）不适用
The role of doxycycline in the management of diastolic dysfunction - The role of doxycycline in the management of diastolic dysfunction
适应症
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
- •Treated for hypertension > 6 months
- •Doppler-echocardiographic evidence of severe diastolic dysfunction (see Echo Doppler investigation below)
- •Clinically stable (on same treatment for > 1 month)
- •Informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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.Tetracycline allergy
- •3.Pre-menopausal women (defined as last menstrual period <12 months earlier) (ie postmenopausal women only will be eligible for enrolment. Postmenopausal is defined as 12 months with no menses without an alternative medical cause.
- •4.Prior documented LVEF <45% or qualitative moderate or severe LV systolic dysfunction
- •5.Change in diuretics within 1 month or recent admission for acute decompensated heart failure/ cardiovascular event (eg ischemia) < 3 months
- •6.Haemodynamically severe valvular heart disease
- •7.Evidence of significant inflammatory disease, connective tissue disease, hepatic disease, metabolic bone disease which may alter parameters of collagen metabolism
- •8.Hypertrophic, restrictive or constrictive cardiomyopathy
- •9.Clinically significant pulmonary disease as evidenced by hospitalisations or use of oral corticosteroids for pulmonary decompensation within 12 months, or requirement for home O2 or significant fibrosis
- •10.Severe anaemia (Haemoglobin <8.0g/dL)
- •11.Severe renal dysfunction (GFR < 30 mL/min/1.73m2)
- •The estimated GFR (eGFR) will be calculated by 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).
- •12.Subjects with hepatic dysfunction (one or more LFTs greater than three times the upper limit of normal)
- •13.Gastro-oesophageal reflux disease
- •14.Recent trauma or surgery (<6 months)
- •15.Malignancy
- •16.Subjects with contraindications to MRI
- •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.Insulin pump
- •i.Metal shrapnel or bullet.
- •17.Contraindications to doxycycline therapy:
- •a.Use in subjects with hypersensitivity to tetracyclines
- •b.Use during pregnancy or breast feeding
- •c.Obstructive oesophageal disorders such as stricture or achalasia.
- •18.Subjects on cyclosporin.
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