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
<p><strong>Background:</strong></p> 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. <p><strong>Aims:</s...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Other Authors: | |
| Format: | Journal article |
| Language: | English |
| Published: |
SAGE Publications
2022
|
| _version_ | 1797110532696702976 |
|---|---|
| author | Kopczak, A Stringer, MS van den Brink, H Kerkhofs, D Blair, GW van Dinther, M Onkenhout, L Thrippleton, MJ Wartolowska, KA Duering, M Staals, J Middeke, M André, E Norrving, B Bousser, M-G Mansmann, U Rothwell, PM Doubal, FN van Oostenbrugge, R Jan Biessels, G Webb, AJS Wardlaw, JM Dichgans, M |
| author2 | SVDs@target consortium |
| author_facet | SVDs@target consortium Kopczak, A Stringer, MS van den Brink, H Kerkhofs, D Blair, GW van Dinther, M Onkenhout, L Thrippleton, MJ Wartolowska, KA Duering, M Staals, J Middeke, M André, E Norrving, B Bousser, M-G Mansmann, U Rothwell, PM Doubal, FN van Oostenbrugge, R Jan Biessels, G Webb, AJS Wardlaw, JM Dichgans, M |
| author_sort | Kopczak, A |
| collection | OXFORD |
| description | <p><strong>Background:</strong></p>
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.
<p><strong>Aims:</strong></p>
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.
<p><strong>Design:</strong></p>
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.
<p><strong>Outcomes:</strong></p>
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).
<p><strong>Discussion:</strong></p>
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.
<p><strong>Funding:</strong></p>
European Union’s Horizon 2020 programme. |
| first_indexed | 2024-03-07T07:56:11Z |
| format | Journal article |
| id | oxford-uuid:887d0259-0d6f-4fb3-9b18-83a2da4157f4 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:56:11Z |
| publishDate | 2022 |
| publisher | SAGE Publications |
| record_format | dspace |
| spelling | oxford-uuid:887d0259-0d6f-4fb3-9b18-83a2da4157f42023-08-17T11:26:31ZThe 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 trialJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:887d0259-0d6f-4fb3-9b18-83a2da4157f4EnglishSymplectic ElementsSAGE Publications2022Kopczak, AStringer, MSvan den Brink, HKerkhofs, DBlair, GWvan Dinther, MOnkenhout, LThrippleton, MJWartolowska, KADuering, MStaals, JMiddeke, MAndré, ENorrving, BBousser, M-GMansmann, URothwell, PMDoubal, FNvan Oostenbrugge, RJan Biessels, GWebb, AJSWardlaw, JMDichgans, MSVDs@target consortium<p><strong>Background:</strong></p> 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. <p><strong>Aims:</strong></p> 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. <p><strong>Design:</strong></p> 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. <p><strong>Outcomes:</strong></p> 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). <p><strong>Discussion:</strong></p> 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. <p><strong>Funding:</strong></p> European Union’s Horizon 2020 programme. |
| spellingShingle | Kopczak, A Stringer, MS van den Brink, H Kerkhofs, D Blair, GW van Dinther, M Onkenhout, L Thrippleton, MJ Wartolowska, KA Duering, M Staals, J Middeke, M André, E Norrving, B Bousser, M-G Mansmann, U Rothwell, PM Doubal, FN van Oostenbrugge, R Jan Biessels, G Webb, AJS Wardlaw, JM Dichgans, M 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 |
| work_keys_str_mv | AT kopczaka theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT stringerms theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT vandenbrinkh theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT kerkhofsd theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT blairgw theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT vandintherm theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT onkenhoutl theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT thrippletonmj theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT wartolowskaka theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT dueringm theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT staalsj theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT middekem theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT andree theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT norrvingb theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT boussermg theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT mansmannu theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT rothwellpm theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT doubalfn theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT vanoostenbrugger theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT janbiesselsg theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT webbajs theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT wardlawjm theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT dichgansm theeffectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT kopczaka effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT stringerms effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT vandenbrinkh effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT kerkhofsd effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT blairgw effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT vandintherm effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT onkenhoutl effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT thrippletonmj effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT wartolowskaka effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT dueringm effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT staalsj effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT middekem effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT andree effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT norrvingb effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT boussermg effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT mansmannu effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT rothwellpm effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT doubalfn effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT vanoostenbrugger effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT janbiesselsg effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT webbajs effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT wardlawjm effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial AT dichgansm effectsofamlodipineandotherbloodpressureloweringagentsonmicrovascularfunctioninsmallvesseldiseasestreatsvdstrialstudyprotocolforarandomisedcrossovertrial |