Clinical Trial: Effects of Amlodipine and Other Blood Pressure Lowering Agents on Microvascular Function
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: EffecTs of Amlodipine and Other Blood PREssure Lowering Agents on Microvascular FuncTion in Small Vessel Diseases
Brief 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)
Detailed Summary:
TREAT-SVDs will be carried out as a multicentre open label trial at five trial sites across 3 European countries: Germany, the Netherlands, and the United Kingdom.
Patients meeting eligibility criteria will be randomly allocated to one of three sequences of antihypertensive treatment which are given as open-label oral medications in standard dose in the following order
Arm A: Amlodipine > Losartan > Atenolol
Arm B: Atenolol > Amlodipine > Losartan
Arm C: Losartan > Atenolol > Amlodipine.
The study starts with a two week run-in phase. During these first two weeks, patients are not allowed to take antihypertensive drugs except for the rescue medication. After the run-in period,every patient will take subsequently three different antihypertensive drugs (each drug from a separate drug class) according to the randomly assigned arm. Each study drug will be administered for four weeks.
Patients will be monitored telemetrically with a dedicated BP device during the whole trial period of 14 weeks.
Sponsor: Ludwig-Maximilians - University of Munich
Current Primary Outcome: Change from Baseline Cerebrovascular Reactivity (CVR) at 4 weeks of Monotherapy [ Time Frame: baseline measure at the end of the run-in phase (week 2); after 4 weeks of each monotherapy (week 6, week 10, and week 14) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from Baseline Mean Systolic Blood Pressure (SBP) at the last week of each treatment phase [ Time Frame: within the last week of the run-in phase and within the last week of each treatment phase ]Mean SBP assessed by daily telemetric monitoring within the last week of the run-in phase and within the last week of each treatment phase
- Change from Baseline Blood Pressure Variability (BPv) at the last week of each treatment phase [ Time Frame: within the last week of the run-in phase and within the last week of each treatment phase ]BPv operationalized as coefficient of variation (100*std/mean SBP) across multiple measurements and assessed by daily telemetric monitoring within the last week of the run-in phase and within the last week of each treatment phase
Original Secondary Outcome: Same as current
Information By: Ludwig-Maximilians - University of Munich
Dates:
Date Received: March 8, 2017
Date Started: August 1, 2017
Date Completion: September 30, 2020
Last Updated: March 16, 2017
Last Verified: March 2017