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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
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
SAGE Publications
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10069218/ https://www.ncbi.nlm.nih.gov/pubmed/37021189 http://dx.doi.org/10.1177/23969873221143570 |
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author | Kopczak, Anna Stringer, Michael S van den Brink, Hilde Kerkhofs, Danielle Blair, Gordon W van Dinther, Maud Onkenhout, Laurien Wartolowska, Karolina A Thrippleton, Michael J Duering, Marco Staals, Julie Middeke, Martin André, Elisabeth Norrving, Bo Bousser, Marie-Germaine Mansmann, Ulrich Rothwell, Peter M Doubal, Fergus N van Oostenbrugge, Robert Biessels, Geert Jan Webb, Alastair JS Wardlaw, Joanna M Dichgans, Martin |
author_facet | Kopczak, Anna Stringer, Michael S van den Brink, Hilde Kerkhofs, Danielle Blair, Gordon W van Dinther, Maud Onkenhout, Laurien Wartolowska, Karolina A Thrippleton, Michael J Duering, Marco Staals, Julie Middeke, Martin André, Elisabeth Norrving, Bo Bousser, Marie-Germaine Mansmann, Ulrich Rothwell, Peter M Doubal, Fergus N van Oostenbrugge, Robert Biessels, Geert Jan Webb, Alastair JS Wardlaw, Joanna M Dichgans, Martin |
author_sort | Kopczak, Anna |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10069218 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | SAGE Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-100692182023-04-04 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 Kopczak, Anna Stringer, Michael S van den Brink, Hilde Kerkhofs, Danielle Blair, Gordon W van Dinther, Maud Onkenhout, Laurien Wartolowska, Karolina A Thrippleton, Michael J Duering, Marco Staals, Julie Middeke, Martin André, Elisabeth Norrving, Bo Bousser, Marie-Germaine Mansmann, Ulrich Rothwell, Peter M Doubal, Fergus N van Oostenbrugge, Robert Biessels, Geert Jan Webb, Alastair JS Wardlaw, Joanna M Dichgans, Martin Eur Stroke J Original Research Articles 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. SAGE Publications 2022-12-16 2023-03 /pmc/articles/PMC10069218/ /pubmed/37021189 http://dx.doi.org/10.1177/23969873221143570 Text en © European Stroke Organisation 2022 https://creativecommons.org/licenses/by/4.0/This article is distributed under the terms of the Creative Commons Attribution 4.0 License (https://creativecommons.org/licenses/by/4.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage). |
spellingShingle | Original Research Articles Kopczak, Anna Stringer, Michael S van den Brink, Hilde Kerkhofs, Danielle Blair, Gordon W van Dinther, Maud Onkenhout, Laurien Wartolowska, Karolina A Thrippleton, Michael J Duering, Marco Staals, Julie Middeke, Martin André, Elisabeth Norrving, Bo Bousser, Marie-Germaine Mansmann, Ulrich Rothwell, Peter M Doubal, Fergus N van Oostenbrugge, Robert Biessels, Geert Jan Webb, Alastair JS Wardlaw, Joanna M Dichgans, Martin 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 |
title | 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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Original Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10069218/ https://www.ncbi.nlm.nih.gov/pubmed/37021189 http://dx.doi.org/10.1177/23969873221143570 |
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