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) ]

The primary outcome variable is CVR as determined by blood oxygen level-dependent (BOLD) MRI (T2*) brain scan response to hypercapnic challenge at the end of the 2 week run-in phase and after 4 weeks of monotherapy while still on medication.


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