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Hypertensive treatment in older adults with vascular brain lesions: should we SPRINT faster?


- candidate number27798
- NTR NumberNTR6661
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-aug-2017
- Secondary IDs2017.099 METC VUmc
- Public TitleHypertensive treatment in older adults with vascular brain lesions: should we SPRINT faster?
- Scientific TitleHypertensive treatment in older adults with cerebral small vessel disease: should we SPRINT faster?
- ACRONYMSPRINT2017
- hypothesisTo test if intensive control (SBP 120 mmHg) decreases cerebral blood flow velocity compared to conventional targets (SBP<140-150 mmHg) in PB in patients with CSVD and hypertension.
- Healt Condition(s) or Problem(s) studiedHypertension, Cerebral small vessel disease (CSVD)
- Inclusion criteria ≥ 65 years of age
High systolic blood pressure of 150-200mmHg based on the average of a daytime 24-hour BP (with or without taking antihypertensive medication)
Cerebral small vessel disease (white matter lesions; Fazekas score ≥ 2) on MRI
- Exclusion criteria Medical history of diabetes mellitus
Experienced myocardial infarction within the past 12 months
Medical history of stroke in the past 6 months or large (sub) cortical cerebral infarction on MRI
Medical history of end stage heart failure (NYHA III-IV)
Stage 4-5 kidney failure
Diagnosed with dementia
Life expectancy less than 1 year
Unable to obtain an optimal window for TCD measurements during first visit at the outward patient clinic
Significant stenosis (>70%) of the left of right common carotid artery
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 30-sep-2017
- planned closingdate1-sep-2019
- Target number of participants20
- Interventionsintensive control (SBP ≤120 mmHg)
- Primary outcomecerebral blood flow velocity
- Secondary outcomecognitive functioning, white matter lesions, orthostatic hypotension, dynamic cerebral autoregulatory capacity, CO2 responsiveness, experienced side effects, disability to reach assigned BP target
- Timepointsbaseline, after 4 months of follow-up
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESdr. Emma Kleipool
- CONTACT for SCIENTIFIC QUERIESdr. Emma Kleipool
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Institute for Cardiovascular Research
- Publications
- Brief summaryPilot trial testing the effect of intensive control (SBP ≤120 mmHg) versus conventional targets (SBP<140-150 mmHg) on cerebral blood flow velocity in older (≤ 65 yrs) hypertensive patients with cerebral small vessel disease. Secondary objectives are to test the effect of tight blood pressure control on cognitive functioning, degree of white matter lesions and unacceptable side-effects of antihypertensive drugs.
- Main changes (audit trail)
- RECORD28-aug-2017 - 8-sep-2017


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