Blood Pressure Management for Kidney Disease

Recruiting in Palo Alto (17 mi)

Overseen byNavdeep Tangri, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Manitoba

No Placebo Group

Trial Summary

What is the purpose of this trial?High blood pressure in people receiving hemodialysis is known to contribute to heart disease and heart-related death from strokes, heart failure, left ventricular hypertrophy (which is a thickening of the heart wall that makes it difficult for the heart to pump blood) and arrythmias (an irregular or abnormal heartbeat). In comparison, low blood pressure can lead to cramps, myocardial stunning, and cerebrovascular ischemia. However, despite, blood pressure management being an important component of hemodialysis care, the "best" blood pressure target for people on hemodialysis is unknown. Finding the "right" blood pressure to target can have a major impact on patient lives. We are proposing a large, pragmatic, cluster randomized trial targeting a lower versus higher blood pressure target in in-centre hemodialysis units in Canada. Our initial steps towards this bigger trial are to run a smaller trial including 4 units, to evaluate whether it is feasible to conduct a larger trial. Our ultimate goal is to deliver the definitive randomized trial for blood pressure targets in the hemodialysis population.

Eligibility Criteria

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.

Inclusion Criteria

I am older than 18 years.

I am receiving hemodialysis in a center at least twice a week.

I started dialysis over 90 days ago.

Exclusion Criteria

Life expectancy < 4 months

Pregnancy, anticipated pregnancy, or breastfeeding

Unmeasurable SBP (e.g., have left ventricular assist device)

+6 more

Participant Groups

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.

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