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Central Blood Pressure Monitoring Devices for Chronic Kidney Disease (CBP-REIN Trial)

N/A
Recruiting
Research Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80 years old
Be older than 18 years old
Must not have
Arm circumference incompatible with the blood pressure cuffs for all devices (<18 cm or > 50 cm)
Ongoing atrial fibrillation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at enrollment (time 0)
Awards & highlights
No Placebo-Only Group

Summary

This trial compares BP readings from 4 non-invasive devices to measure central aortic blood pressure. The goal is to determine the accuracy of each device.

Who is the study for?
This trial is for kidney disease patients aged 18-80 who can consent to participate. It's not suitable for those with ongoing atrial fibrillation or an arm circumference that doesn't fit the blood pressure cuffs (<18 cm or >50 cm).
What is being tested?
The study tests how well four different devices agree on measuring central blood pressure in a non-invasive way. These are Mobil-o-Graph NG, WatchBP Office, BP+ device, and Oscar 2 with SphygmoCor inside.
What are the potential side effects?
Since this trial involves standard non-invasive blood pressure measurements, side effects are minimal but may include temporary discomfort from cuff inflation similar to routine blood pressure checks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My arm circumference is either less than 18 cm or more than 50 cm.
Select...
I currently have atrial fibrillation.
Select...
I am unable to understand and give consent for treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at enrollment (time 0)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at enrollment (time 0) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Central SBP difference
Secondary study objectives
Brachial DBP difference
Brachial SBP difference
Central DBP difference

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Hypertension groupExperimental Treatment1 Intervention
Patients with BP \> 135/85 mmHg or taking any antihypertensive medication with normal kidney function (eGFR \> 60 ml/min/1.73m2)
Group II: Dialysis groupsExperimental Treatment1 Intervention
Patients on hemodialysis or peritoneal dialysis
Group III: Advanced CKD groupExperimental Treatment1 Intervention
Patients with eGFR \< 30 ml/min/1.73m2 not on dialysis
Group IV: Control groupActive Control1 Intervention
Normotensive patients without any antihypertensive drugs or chronic kidney disease

Find a Location

Who is running the clinical trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealLead Sponsor
16 Previous Clinical Trials
4,436 Total Patients Enrolled

Media Library

Advanced CKD group Clinical Trial Eligibility Overview. Trial Name: NCT05963880 — N/A
High Blood Pressure Research Study Groups: Advanced CKD group, Hypertension group, Control group, Dialysis groups
High Blood Pressure Clinical Trial 2023: Advanced CKD group Highlights & Side Effects. Trial Name: NCT05963880 — N/A
Advanced CKD group 2023 Treatment Timeline for Medical Study. Trial Name: NCT05963880 — N/A
~29 spots leftby Apr 2025
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