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Telemonitoring of Hypertensive Patients With Chronic Kidney Disease

RecruitingNAAges 18 Years - anyAllUniversity of Alberta
NCT04098354 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Hypertension, together with poorly controlled blood pressure (BP) are known risk factors for kidney disease and progression to kidney failure as well as increased cardiovascular (CV) morbidity and mortality. Several studies in patients without kidney disease have demonstrated the efficacy of home BP telemonitoring (HBPT) for BP control. Objective: The primary aim of this study is to assess the mean difference in systolic BP (SBP) at 12 months, from baseline in remote dwelling patients with hypertension and chronic kidney disease (CKD) in Northern Alberta, Canada, comparing HBPT + usual care versus HBPT + a case manager. Other secondary objectives, including cost-effectiveness and acceptability of HBPT as well as occurrence of adverse events will also be assessed. Methods Design: This study is designed as a pragmatic randomized controlled trial (RCT) of HBPT plus clinica

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age equal to and more than 18 years with documented diagnosis of established CKD (not on dialysis with eGFR \< 60 mL/min/1.73m2 and/or proteinuria \> 1 g/day) * Remote dwelling patients in the Peace River region of Alberta, Canada * Patients known with hypertension (physician diagnosed / self reported and currently taking antihypertensive medications) * Owning a smartphone (iOS or Android) with access to wireless internet connection. * Proficiency in English language (both verbal and written); and ability and willingness to provide informed consent for participation. * Ability and willingness to use the HBPT device (≥ 80% recordings sent in the training period) Exclusion Criteria: * Patients with hypertensive urgency or emergency identified during the training period (immediate consultation will be initiated with the patient's PCP or with a hypertension specialist) * Patients with stage 5 CKD (eGFR ≤ 15 ml/min/1.73m2) or patients receiving kidney replacement therapy * Heart failure with reduced ejection fraction * Presence of any terminal illness (life expectancy \< 1 year) * Participation in any ongoing clinical drug trial * Pregnancy, lactation / breastfeeding * Planning to relocate out of the Peace River region or residence in an area without mobile phone coverage.
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What it tests

  • home BP telemonitoring system .
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Where

1 site
University of Alberta
Edmonton, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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