EffecTs of Amlodipine and other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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