The EffecTs of Amlodipine and other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases (TREAT-SVDs) trial: Study protocol for a randomised crossover trial

Author:

Kopczak Anna1ORCID,S Stringer Michael2ORCID,van den Brink Hilde3ORCID,Kerkhofs Danielle4,W Blair Gordon2ORCID,van Dinther Maud4,Onkenhout Laurien3,A Wartolowska Karolina5,Thrippleton Michael J2,Duering Marco16,Staals Julie4ORCID,Middeke Martin7,André Elisabeth8,Norrving Bo9,Bousser Marie-Germaine10,Mansmann Ulrich11,Rothwell Peter M5ORCID,N Doubal Fergus2,van Oostenbrugge Robert4,Jan Biessels Geert3,Webb Alastair JS5ORCID,Wardlaw Joanna M212ORCID,Dichgans Martin11314

Affiliation:

1. Institute for Stroke and Dementia Research, University Hospital, LMU Munich, Munich, Germany

2. Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK

3. Department of Neurology, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands

4. Department of Neurology and School for cardiovascular diseases (CARIM), Maastricht University Medical Center+, Maastricht, The Netherlands

5. Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK

6. Medical Image Analysis Center (MIAC AG) and Department of Biomedical Engineering, University of Basel, Basel, Switzerland

7. Hypertoniezentrum München, Excellence Centre of the European Society of Hypertension (ESH), Munich, Germany

8. Münchner Studienzentrum, Faculty of Medicine, Technical University Munich (TUM), Munich, Germany

9. Neurology, Department of Clinical Sciences Lund, Lund University, and Neurology, Skåne University Hospital Lund/Malmö, Sweden

10. Hôpital Lariboisière, APHP, Université Paris-Cité, Paris, France

11. Institute for Medical Information Processing, Biometry, and Epidemiology, LMU Munich, Munich, Germany

12. UK Dementia Research Institute, University of Edinburgh, Edinburgh, UK

13. Munich Cluster for Systems Neurology (SyNergy), Munich, Germany

14. German Center for Neurodegenerative Diseases (DZNE), Munich, Germany

Abstract

Background: Hypertension is the leading modifiable risk factor for cerebral small vessel diseases (SVDs). Yet, it is unknown whether antihypertensive drug classes differentially affect microvascular function in SVDs. Aims: To test whether amlodipine has a beneficial effect on microvascular function when compared to either losartan or atenolol, and whether losartan has a beneficial effect when compared to atenolol in patients with symptomatic SVDs. Design: TREAT-SVDs is an investigator-led, prospective, open-label, randomised crossover trial with blinded endpoint assessment (PROBE design) conducted at five study sites across Europe. Patients aged 18 years or older with symptomatic SVD who have an indication for antihypertensive treatment and are suffering from either sporadic SVD and a history of lacunar stroke or vascular cognitive impairment (group A) or CADASIL (group B) are randomly allocated 1:1:1 to one of three sequences of antihypertensive treatment. Patients stop their regular antihypertensive medication for a 2-week run-in period followed by 4-week periods of monotherapy with amlodipine, losartan and atenolol in random order as open-label medication in standard dose. Outcomes: The primary outcome measure is cerebrovascular reactivity (CVR) as determined by blood oxygen level dependent brain MRI signal response to hypercapnic challenge with change in CVR in normal appearing white matter as primary endpoint. Secondary outcome measures are mean systolic blood pressure (BP) and BP variability (BPv). Discussion: TREAT-SVDs will provide insights into the effects of different antihypertensive drugs on CVR, BP, and BPv in patients with symptomatic sporadic and hereditary SVDs. Funding: European Union’s Horizon 2020 programme. Trial registration: NCT03082014.

Funder

Horizon 2020 Framework Programme

Publisher

SAGE Publications

Subject

Cardiology and Cardiovascular Medicine,Neurology (clinical)

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