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 Netherlands
Prof. Geert Jan Biessels

Oxford

Nuffield Department of Clinical NeurosciencesUniversity of Oxford, John Radcliffe Hospital, Oxford,United Kingdom
Prof. 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)

           

          Antihypertensive Drugs


          • Amlodipine
            (calcium channel blocker)
            • Losartan
              (AT1-receptor blocker)
              • Atenolol
                (beta-blocker)

               

              You will receive all three drugs; each one for 4 weeks. The order of drugs will be randomly assigned.
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Publications with PubMed ID

Authors: Stringer MS, Lee H, Huuskonen MT, MacIntosh BJ, Brown R, Montagne A, Atwi S, Ramirez J, Jansen MA, Marshall I, Black SE, Zlokovic BV, Benveniste H, Wardlaw JM

Translational stroke research. 2020 Sep 16;

PMID: 32936435

Authors: Elschot EP, Backes WH, Postma AA, van Oostenbrugge RJ, Staals J, Rouhl RPW, Jansen JFA

Investigative radiology. 2020 Sep 15;

PMID: 32932377

Authors: Hablitz LM, Plá V, Giannetto M, Vinitsky HS, Stæger FF, Metcalfe T, Nguyen R, Benrais A, Nedergaard M

Nature communications. 2020 Sep 2;11(1):4411

PMID: 32879313    Open Access: PMC7468152

Authors: Kerkhofs D, van Hagen BT, Milanova IV, Schell KJ, van Essen H, Wijnands E, Goossens P, Blankesteijn WM, Unger T, Prickaerts J, Biessen EA, van Oostenbrugge RJ, Foulquier S

Theranostics. 2020;10(21):9512-9527

PMID: 32863942    Open Access: PMC7449902

Authors: Lee YK, Rothwell PM, Payne SJ, Webb AJS

Physiological measurement. 2020 Aug 7;

PMID: 32764198

Authors: Gill D, Georgakis MK, Zuber V, Karhunen V, Burgess S, Malik R, Dichgans M

Journal of the American Heart Association. 2020 Jul 21;9(14):e016773

PMID: 32627641

Authors: Georgakis MK, Gill D, Malik R, Protogerou AD, Webb AJS, Dichgans M

Hypertension (Dallas, Tex. : 1979). 2020 Sep;76(3):953-961

PMID: 32623925    Open Access: PMC7418931

Authors: Asare Y, Campbell-James TA, Bokov Y, Yu LL, Prestel M, El Bounkari O, Roth S, Megens RTA, Straub T, Thomas K, Yan G, Schneider M, Ziesch N, Tiedt S, Silvestre-Roig C, Braster Q, Huang Y, Schneider M, Malik R, Haffner C, Liesz A, Soehnlein O, Bernhagen J, Dichgans M

Circulation research. 2020 Aug 28;127(6):811-823

PMID: 32546048

Authors: Georgakis MK, Gill D, Webb AJS, Evangelou E, Elliott P, Sudlow CLM, Dehghan A, Malik R, Tzoulaki I, Dichgans M

Neurology. 2020 Jul 28;95(4):e353-e361

PMID: 32611631    Open Access: PMC7455321

Authors: Mestre H, Mori Y, Nedergaard M

Trends in neurosciences. 2020 Jul;43(7):458-466

PMID: 32423764    Open Access: PMC7331945

Authors: Biessels GJ, Nobili F, Teunissen CE, Simó R, Scheltens P

The Lancet. Neurology. 2020 Aug;19(8):699-710

PMID: 32445622

Authors: Blair GW, Thrippleton MJ, Shi Y, Hamilton I, Stringer M, Chappell F, Dickie DA, Andrews P, Marshall I, Doubal FN, Wardlaw JM

Neurology. 2020 May 26;94(21):e2258-e2269

PMID: 32366534    Open Access: PMC7357294

Authors: Ratelade J, Klug NR, Lombardi D, Angelim MKSC, Dabertrand F, Domenga-Denier V, Salman RA, Smith C, Gerbeau JF, Nelson MT, Joutel A

Circulation. 2020 Jun 23;141(25):2078-2094

PMID: 32183562    Open Access: PMC7311305

Authors: Li Q, Aalling NN, Förstera B, Ertürk A, Nedergaard M, Møllgård K, Xavier ALR

Fluids and barriers of the CNS. 2020 Feb 11;17(1):15

PMID: 32046744    Open Access: PMC7014736

Authors: Georgakis MK, Malik R, Anderson CD, Parhofer KG, Hopewell JC, Dichgans M

Brain : a journal of neurology. 2020 Feb 1;143(2):597-610

PMID: 31968102    Open Access: PMC7009571

Authors: Sloots JJ, Biessels GJ, Zwanenburg JJM

NeuroImage. 2020 Apr 15;210:116581

PMID: 31982580

Authors: Mestre H, Du T, Sweeney AM, Liu G, Samson AJ, Peng W, Mortensen KN, Stæger FF, Bork PAR, Bashford L, Toro ER, Tithof J, Kelley DH, Thomas JH, Hjorth PG, Martens EA, Mehta RI, Solis O, Blinder P, Kleinfeld D, Hirase H, Mori Y, Nedergaard M

Science (New York, N.Y.). 2020 Mar 13;367(6483)

PMID: 32001524    Open Access: PMC7375109

Authors: Abraham G, Malik R, Yonova-Doing E, Salim A, Wang T, Danesh J, Butterworth AS, Howson JMM, Inouye M, Dichgans M

Nature communications. 2019 Dec 20;10(1):5819

PMID: 31862893    Open Access: PMC6925280