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Behavioural Intervention
Blood Pressure Management for Kidney Disease
N/A
Waitlist Available
Led By Navdeep Tangri, MD, PhD
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years old
Undergoing in-centre hemodialysis at least twice weekly
Must not have
Inability to measure blood pressures in an upper arm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 11 to13
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to determine the best blood pressure target for people receiving hemodialysis. High blood pressure can lead to heart problems, while low blood pressure can cause cramps and other issues. The study
Who is the study for?
This trial is for individuals on in-center hemodialysis due to kidney disease. It aims to find the best blood pressure target to reduce heart-related issues and other complications. Participants must be receiving regular hemodialysis treatments at one of the participating Canadian centers.
What is being tested?
The study is testing whether a lower or higher systolic blood pressure target is better for patients undergoing hemodialysis. This small-scale trial with four units will determine if it's possible to conduct a larger, more definitive trial across Canada.
What are the potential side effects?
Potential side effects from adjusting blood pressure targets may include heart strain, stroke risk, irregular heartbeat for higher targets; cramps, myocardial stunning (temporary loss of heart function), and cerebrovascular ischemia (reduced brain blood flow) for lower targets.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I am receiving hemodialysis in a center at least twice a week.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot have my blood pressure taken in my upper arm.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 11 to13
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 11 to13
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in blood pressure between arms
Secondary study objectives
Feasibility Outcomes - Change since baseline
Feasibility Outcomes - Proportions
Incidence of Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy)Experimental Treatment2 Interventions
The approach to reach blood pressure target is up to the treating physician. Depending on baseline pre-dialysis systolic blood pressure, blood pressure may need to be raised or lowered to reach the target.
Group II: Higher pre-dialysis blood pressure target (150-170 mm Hg systolic) (as a unit-level policy)Active Control2 Interventions
The approach to reach blood pressure target is up to the treating physician. Depending on baseline pre-dialysis systolic blood pressure, blood pressure may need to be raised or lowered to reach the target.
Find a Location
Who is running the clinical trial?
University of ManitobaLead Sponsor
621 Previous Clinical Trials
206,503 Total Patients Enrolled
Navdeep Tangri, MD, PhDPrincipal InvestigatorUniversity of Manitoba
1 Previous Clinical Trials
40 Total Patients Enrolled