NL-OMON53102已完成3 期
EffecTs of Amlodipine and other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases - TREAT-SVDs
Klinikum der Universität München (KUM)0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- •Symptomatic SVD defined as
- •- a history compatible with clinical lacunar stroke syndrome in the last 5
- •years with a small subcortical infarct visible on MRI scan or CT scan
- •compatible with the clinical syndrome
- •- or cognitive impairment defined as visiting a memory clinic with cognitive
- •complains*, and capacity to and capacity to consent with confluent deep WMH on
- •MRI (defined on the Fazekas scale as deep WMH score >= 2).
- •*concluded by the treating physician based on a validated cognitive measurement
- •tool (for example but not limited to MoCA or CAMCOG)
- •-or a diagnosis of CADASIL (NOTCH 3 mutation carriers)
- •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
排除标准
- •Inclusion criteria are not met,
- •Unwillingness or inability to give written consent,
- •Pregnant or breastfeeding women, women of childbearing age not taking
- •contraception. ,
- •Contraindications to MRI (pacemaker, aneurysm clip, cochlear implant etc.) ,
- •Other major neurological or psychiatric conditions affecting the brain and
- •interfering with the study design (e.g. multiple sclerosis), In case of
- •clinical lacunar stroke other causes of stroke such as
- •o >=50% luminal stenosis (NASCET) in large arteries supplying the infarct area
- •o 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)
- •o other specific causes of stroke (e.g. arteritis, dissection, migraine/
- •vasospasm, drug misuse) ,
- •Other stroke risk factor requiring immediate intervention that would preclude
- •involvement in the study,
- •Renal impairment (eGFR <35 ml/min),
- •Panic disorder,
- •Life expectancy <2 years,
- •Use of >2 antihypertensive drugs at maximum dose or equivalent (one drug at
- •the maximum dose and two drugs at half of the maximum dose) for an appropriate
- •BP control,
- •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)
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