Blood Pressure Management for Kidney Disease

Overseen By Oksana Harasemiw, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Disqualifiers: Pregnancy, Life expectancy < 4 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal blood pressure targets for individuals undergoing hemodialysis, a treatment for kidney disease. The aim is to determine whether targeting a higher or lower blood pressure is more beneficial, as both extremes can lead to serious health issues. Participants will join a group targeting either a higher blood pressure range (150-170 mm Hg) or a lower range (110-140 mm Hg) before dialysis sessions. The study seeks individuals who have received in-center hemodialysis at least twice a week for over 90 days. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance dialysis care for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that targeting a lower top number in blood pressure, such as 110 to 130, does not increase the risk of kidney problems compared to aiming for 130 or higher. Some studies suggest that maintaining a blood pressure around 125/73 might reduce the risk of kidney disease compared to slightly higher levels. However, concerns exist that very low blood pressure could cause sudden kidney damage.

For higher blood pressure targets, like 150-170, the evidence remains unclear. Typically, lower targets are recommended for individuals with kidney issues, but the optimal target for those on hemodialysis is still under investigation. This trial seeks to determine the best blood pressure levels to support patients during hemodialysis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard approach that often focuses on a one-size-fits-all blood pressure target for kidney disease patients, this trial explores tailored blood pressure management. Researchers are excited about potentially finding the optimal systolic blood pressure range for individual patients, which might improve kidney health and overall outcomes. By testing both higher and lower blood pressure targets, this trial could reveal more personalized treatment strategies, moving beyond the generalized thresholds currently used.

What evidence suggests that this trial's treatments could be effective for blood pressure management in kidney disease?

This trial will compare different blood pressure targets for patients with kidney disease. Research has shown that setting a lower blood pressure goal before dialysis might help reduce heart problems and slow kidney disease progression. Some participants in this trial will aim for a lower pre-dialysis blood pressure target of 110-140 mm Hg systolic. Other studies suggest that a higher target, between 150 and 170, might benefit some individuals by preventing issues like cramps or dizziness. In this trial, another group will aim for this higher pre-dialysis blood pressure target. The best blood pressure target can vary based on individual health needs, so finding the right balance is important. ^{1 2 5 6 7}

Who Is on the Research Team?

Navdeep Tangri, MD, PhD

Principal Investigator

University of Manitoba

Are You a Good Fit for This Trial?

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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Implementation of a pre-dialysis blood pressure protocol with a higher versus lower target

3 months

Check-ins at weeks 4 and 8

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Decrease systolic blood pressure
• Increase systolic blood pressure

Trial Overview 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.

How Is the Trial Designed?

Group I: Lower pre-dialysis blood pressure target (110-140 mm Hg systolic) (as a unit-level policy) Experimental Treatment 2 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 Control 2 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.

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Published Research Related to This Trial

In a study of 6427 older patients (average age 80) with hypertension, the best cardiovascular outcomes were observed in those with an average systolic blood pressure (SBP) of 120-129 mmHg, indicating a J-shaped relationship between SBP and adverse events.

Maintaining an SBP of less than 130 mmHg was linked to improved health outcomes without significant safety issues, supporting the recommendation to target this level in older patients if they can tolerate it.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular outcomes according to on-treatment systolic blood pressure in older hypertensive patients: a multicenter cohort using a common data model. Kim, JH., Joo, HJ., Chung, SH., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8273817/

Blood pressure control in patients with chronic kidney ... In this review, we discuss the optimal control of BP in patients with CKD in terms of reduction in death and CVEs as well as attenuation of CKD progression.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836388

Intensive Systolic Blood Pressure Reduction and Kidney ... A subgroup analysis of the SPRINT study showed that a SBP less than 120 mm Hg increased 2.6% of kidney outcomes compared with a SBP less than ...

3. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.121.18434

Is the KDIGO Systolic Blood Pressure Target <120 mm Hg ... We believe the KDIGO-recommended target systolic BP <120 mm Hg for CKD is inappropriate in the majority of CKD patients and it may even be harmful.

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2022.813603/full

Intensive Systolic Blood Pressure Lowering and Kidney ... This study aims to evaluate the association of SBP and the progression of IgAN, then explore whether lowering SBP from <140– <120 mm Hg is renoprotective.

5. ajkdblog.org ajkdblog.org/2025/05/28/exploring-the-optimal-blood-pressure-target-in-advanced-ckd/

Exploring the Optimal Blood Pressure Target in Advanced ... The optimal SBP target in patients with advanced CKD remains controversial due to concerns over potential adverse effects such as acute kidney injury (AKI), ...

6. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.125.25902

Encouraged by the 2025 US Guidelines to Lower Systolic ... Overall, the 3 guidelines' unanimous recommendation of a systolic BP target lower than 130 mm Hg is well supported. Several randomized clinical ...

7. nature.com nature.com/articles/s41598-024-71019-9

The effect of different levels of systolic blood pressure ... Meta-analysis showed that blood pressure level of 125/73 mmHg was associated with a lower risk of composite kidney disease than 134/79 mmHg.