Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To determine the feasibility and value of remote blood pressure (BP) monitoring during a clinical trial of isradipine (a dihydropyridine calcium channel antagonist) in early Parkinson’s disease (PD).
Background: Orthostatic hypotension is common in PD and clinical trials evaluating blood pressure lowering treatments may require BP monitoring for safety. This monitoring has traditionally been in the form of home BP logs, which allow for frequent readings, but cannot be reviewed in real time for safety and are unable to ensure data integrity or protocol compliance. Remote real time BP monitoring can increase study safety, validity and compliance. Steady-PDIII is a phase III randomized placebo-controlled trial of the efficacy of isradipine on the progression of PD disability that utilized remote BP monitoring to ensure safety and to facilitate dosage titration.
Methods: Subjects were required to take sit and stand BP readings twice daily during screening and drug titration. BP readings are sent from the BP monitor to an online database in real time, which is reviewed by a clinical BP monitor. BP readings outside the safety range (90-160mm of Hg systolic, 60-90mm of Hg diastolic) were flagged by the system with orthostatic reads identified manually. We evaluated the frequency of BP monitoring, participant compliance with the BP protocol, and the frequency of clinical interventions necessitated by BP readings.
Results: 382 Participants completed 17,682 days of monitoring and 70,956 total BP readings. Review of protocol compliance revealed that readings were not taken the required number of times on 26% of the days and 48% of participants did not take BP readings as specified in the protocol. The clinical monitor contacted sites for 48 subjects (12.6%) for out of range or orthostatic readings. As a result, 2 subjects re-initiated home BP readings, 7 subjects were excluded based on out of range BP readings, and 3 subjects had study drug dosage reductions.
Conclusions: Remote BP monitoring in a clinical trial is feasible and allows for faster response to potential safety concerns. Subjects are capable of managing the technical issues of home monitoring and compliance to the BP protocol was fair. Improvements in participant protocol education may minimize barriers to compliance and further improve patient safety in clinical trials.
To cite this abstract in AMA style:J.L. Adams, R.A. Biemiller, K.L. Andrzejewski, S. Sharma, R.L. Rockhill, B.L. Greco, K.C. Hodgeman, P. Singh, S. Khanuja, T. Simuni, K.M. Biglan. Utilizing remote blood pressure monitoring in a phase III clinical drug trial for Parkinson’s disease [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/utilizing-remote-blood-pressure-monitoring-in-a-phase-iii-clinical-drug-trial-for-parkinsons-disease/. Accessed December 7, 2023.
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MDS Abstracts - https://www.mdsabstracts.org/abstract/utilizing-remote-blood-pressure-monitoring-in-a-phase-iii-clinical-drug-trial-for-parkinsons-disease/