TREAT-SVDs
EffecTs of Amlodipine and other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases
Participating Centres:
LMU Munich (coordinating centre)
Institute for Stroke and Dementia Research. Klinikum der Universität München. Feodor-Lynen-Straße 17, Munich, Germany.Coordinating Investigator: Prof. Dr. Martin Dichgans
Edinburgh
Neuroimaging Sciences and Brain Research Imaging Centre, University of Edinburgh Crewe Rd, Edinburgh, United Kingdom.Prof. Joanna Wardlaw.
Utrecht
Department of Neurology, University Medical Center Maastricht, University of Maastricht. P. Debyelaan 25, Maastricht, The Netherlands.Prof. Dr. Robert van Oostenbrugge
Maastricht
Brain Center Rudolf Magnus, University MedicalCenter Utrecht, Universiteitsweg 100, UtrechtThe NetherlandsProf. Geert Jan Biessels
Oxford
Nuffield Department of Clinical NeurosciencesUniversity of Oxford, John Radcliffe Hospital, Oxford,United KingdomProf. Peter Rothwell
General Information
Type of study: international observational study comparing threeblood pressure medications in small vessel disease
Duration: 2 years
Participants: 105 patients
Status: recruitment ongoing.
Main Inclusion Criteria:
- Clinical features of small vessel disease
- Medical history of hypertension or stroke/TIA
- Age > 18 years
- Currently using no more than 2 blood pressure lowering drugs
Background and Aims
Pathological changes in the small blood vessels of the brain can lead to stroke or to vascular cognitive impairment. High blood pressure is one of the most important risk factors for developing small vessel disease but currently it is not clear which blood pressure lowering drugs are best at improving small blood vessel function. We propose that the function of the small microvessels in the brain can be influenced by medication. This study will investigate the effects of three common blood pressure lowering tablets on the function of the brain's small blood vessels.
TREAT-SVDs is a multicentre, non-commercial pharmaceutical study which will be performed in 3 different countries in Europe (Germany, the Netherlands, UK).
The study will be performed over 2 years and recruit 105 participants.
By participating in this study you will make an important contribution to the research on cerebral small vessel diseases.
We thank you for your interest,
Prof. Martin Dichgans, M.D.
Coordinating Investigator
Magnetic resonance imaging (MRI)
Magnetic resonance imaging is a neuroimaging technique based on magnetic fields. The investigation is not dangerous and is not linked with radiation exposure. Noisy knocking sounds occur during the recording; you will wear earplugs during the scan. For a short time you will breath CO2 to investigate the function of the small vessels in the brain (only once during 7-Tesla MRI).
Your Advantages:
- Stable medical assitance
- No waiting period
- Study nurse as direct contact
- High resolution MRI
- Blood analysis
- Blood pressure monitoring with a premium blood pressure devide
- Comprehensive medical attendance
Study flow
Screen visit
- Physical examination
- Blood drawing
- ECG
- Neuropsychological tests
- Face-to-face interview
- Instructions for how to use blood pressure measuring device
- Supply of rescue medication for hypertension
Individual visits
Time: after 2, 6, 10 and 14 weeks (total duration: 3,5 months)
Place: Outpatient clinic
- Physical examination
- Blood drawing
- MRI scan
- Face-to-face interview
- Supply of study drugs for the next 28 days (not in the last visit)
- Amlodipine
(calcium channel blocker) - Losartan
(AT1-receptor blocker) - Atenolol
(beta-blocker)
Antihypertensive Drugs
You will receive all three drugs; each one for 4 weeks. The order of drugs will be randomly assigned.