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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment to decrease systolic blood pressure for managing kidney disease?

Research shows that lowering systolic blood pressure to below 130 mmHg can significantly reduce the risk of kidney disease progression and improve outcomes in patients with chronic kidney disease. ^{1 2 3 4 5}

Is lowering systolic blood pressure safe for people with kidney disease?

Research shows that lowering systolic blood pressure is generally safe and can reduce the risk of heart disease, stroke, and kidney problems. Studies indicate that reducing systolic blood pressure by 12 to 13 mm Hg over four years can significantly lower the risk of these conditions. ^{2 6 7 8 9}

How does the treatment for blood pressure management in kidney disease differ from other treatments?

This treatment focuses on adjusting systolic blood pressure (the top number in a blood pressure reading) specifically for kidney disease, following new guidelines that suggest a lower target to prevent heart and kidney complications. This approach is unique because it aligns with recent findings that emphasize the importance of precise blood pressure control in chronic kidney disease. ^{1 4 10 11 12}

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.

Research Team

Navdeep Tangri, MD, PhD

Principal Investigator

University of Manitoba

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)

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Hypertension Management in Patients with Chronic Kidney Disease in the Post-SPRINT Era. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Baseline Diastolic Blood Pressure and Cardiovascular Outcomes in SPRINT Participants with Chronic Kidney Disease. [2023]

3. Czech Republic pubmed.ncbi.nlm.nih.gov

[The results of SPRINT study from the point of nephrology]. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Cardiovascular Implications of the 2021 KDIGO Blood Pressure Guideline for Adults With Chronic Kidney Disease. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Association of blood pressure and renal outcome in patients with chronic kidney disease; a post hoc analysis of FROM-J study. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Blood Pressure Targets in CKD: Lessons Learned from SPRINT and Previous Observational Studies. [2018]

7. Netherlands 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Elevated systolic blood pressure and risk of cardiovascular and renal disease: overview of evidence from observational epidemiologic studies and randomized controlled trials. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Intensive blood pressure control is associated with improved patient and graft survival after renal transplantation. [2021]

10. England pubmed.ncbi.nlm.nih.gov

The 2021 KDIGO blood pressure target and the progression of chronic kidney disease: Findings from KNOW-CKD. [2023]

11. Korea (South) pubmed.ncbi.nlm.nih.gov

Blood pressure control in patients with chronic kidney disease. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Chronic kidney disease: optimal blood pressure for kidney disease-lower is not better. [2021]