Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function

Summary

Multicentre, multinational, prospective randomised, open-label, 3 sequence crossover phase III b clinical trial with blinded endpoint assessment (PROBE-design) * in 75 patients with sporadic small vessel diseases (SVDs) and * in 30 patients with cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL)

Timeline

Start

2018-02-22

Primary completion

2022-07-28

Completion

2022-07-28

Outcome

Outcome not reported

Stopped (Enrollment): “completed for the primary study group of sporadic SVD patients, halted prematurely for the additional study group due to slow recruitment at 26 of 30 CADASIL patients in December 2022”

Publications

• Kopczak A, Stringer MS, van den Brink H, Kerkhofs D, Blair GW, van Dinther M, Reyes CA, Garcia DJ, Onkenhout L, Wartolowska KA, Thrippleton MJ, Kampaite A, Duering M, Staals J, Lesnik-Oberstein S, Muir KW, Middeke M, Norrving B, Bousser MG, Mansmann U, Rothwell PM, Doubal FN, van Oostenbrugge R, Biessels GJ, Webb AJS, Wardlaw JM, Dichgans M; TREAT-SVDs collaborators. Effect of blood pressure-lowering agents on microvascular function in people with small vessel diseases (TREAT-SVDs): a multicentre, open-label, randomised, crossover trial. Lancet Neurol. 2023 Nov;22(11):991-1004. doi: 10.1016/S1474-4422(23)00293-4.
• Kopczak A, S Stringer M, van den Brink H, Kerkhofs D, W Blair G, van Dinther M, Onkenhout L, A Wartolowska K, Thrippleton MJ, Duering M, Staals J, Middeke M, Andre E, Norrving B, Bousser MG, Mansmann U, Rothwell PM, N Doubal F, van Oostenbrugge R, Biessels GJ, Webb AJ, 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. Eur Stroke J. 2023 Mar;8(1):387-397. doi: 10.1177/23969873221143570. Epub 2022 Dec 16.

Drugs

Indications