EUCTR2016-002920-10-GB进行中（未招募）1 期
TREAT-SVDs:EffecTs of Amlodipine and other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases - SVDs@target: TREAT-SVDs
Klinikum der Universitaet Muenchen AoeR0 个研究点目标入组 105 人开始时间: 2018年5月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
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
- •Patients may be enrolled in the trial if all of the following criteria have been met:
- •- Symptomatic SVD defined as
- •o History of clinical lacunar stroke in the last 5 years with a corresponding recent small subcortical infarct visible on MRI scan or CT scan* compatible with the clinical syndrome.
- •*On MRI, recent infarct is defined as a DWI lesion on the acute MRI scan. On CT, recent infarct is defined as a novel infarct on CT within 3 weeks after the event that was not visible on the admission CT.
- •o or cognitive impairment defined as visiting a memory clinic with cognitive complaints, and a clinical dementia rating (CDR) score of =0.5, and capacity to consent, and with confluent deep white matter hyperintensities (WMH) on MRI (defined on the Fazekas scale as deep WMH score = 2)
- •o or a diagnosis of CADASIL established by molecular genetic testing of the NOTCH3 gene (presence of an archetypical, cysteine-affecting mutation) or the presence of granular osmiophilic material in ultrastructural, electron microscopy analysis of skin biopsy
- •- Indication for antihypertensive treatment (as defined by meeting one of the following):
- •o Hypertension defined as SBP =140mmHg or diastolic BP (DBP) =90mmHg without antihypertensive treatment or use of an antihypertensive drug for previously diagnosed hypertension
- •o Prior history of stroke or transient ischaemic attack (TIA)
- •- Age 18 years or older
- •- Written 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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients will be excluded from the trial for any of the following reasons:
- •o Inclusion criteria are not met
- •o Unwillingness or inability to give written consent
- •o Pregnant or breastfeeding women, women of childbearing age not taking contraception.
- •Acceptable contraception in women of childbearing age is a highly effective” contraceptive measure as defined by the Clinical Trials Facilitation Group
- •(http://www.hma.eu/fileadmin/dateien/Human_Medicines/01-About_HMA/Working_Groups/CTFG/2014_09_HMA_CTFG_Contraception.pdf) and includes combined (oestrogen and progesterone containing) or progesterone-only contraception associated with inhibition of ovulation, or intrauterine device or bilateral tubal occlusion
- •o Contraindications to MRI (pacemaker, aneurysm clip, cochlear implant etc.)
- •o Other major neurological or psychiatric conditions affecting the brain and interfering with the trial design (e.g. multiple sclerosis)
- •o In case of clinical lacunar stroke syndrome other causes of stroke such as
- •- =50% luminal stenosis (NASCET) in large arteries supplying the area of ischaemia
- •- major-risk cardioembolic source of embolism (permanent or paroxysmal atrial fibrillation, sustained atrial flutter, intracardiac thrombus, prosthetic cardiac valve, atrial myxoma or other cardiac tumours, mitral stenosis, recent (<4 weeks) myocardial infarction, left ventricular ejection fraction less than 30%, valvular vegetations, or infective endocarditis)
- •- other specific causes of stroke identified (e.g. arteritis, dissection, migraine/vasospasm, drug misuse)
- •o Other stroke risk factor requiring immediate intervention that would preclude involvement in the trial
- •o Renal impairment (eGFR <35ml/min)
- •o Life expectancy <2 years
- •o Use of >2 antihypertensive drugs for an appropriate BP control
- •o Contraindications to the applied antihypertensive drugs as known
- •o Severe aortic stenosis
- •o Bilateral renal artery stenosis
- •o Severe arterial circulatory disorders
- •o Atrioventricular block II° or III° or sick sinus syndrome
- •o Heart failure (NYHA III or IV)
- •o Bradycardia, resting heart rate <50/min
- •o Bronchospastic diseases such as severe bronchial asthma
- •o Severe hepatic dysfunction such as liver cirrhosis
- •o Use of monoamine oxidase (MAO)-A-blockers
- •o Use of simvastatin >20mg/d
- •o Metabolic acidosis
- •o Disturbed electrolyte homeostasis such as hypercalcaemia, hypokalaemia, and hyponatraemia
- •o Symptomatic hyperuricaemia (gout)
研究者
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