Central vs Brachial Blood Pressure Targeting for Chronic Kidney Disease

(CENTRAL-CKD Trial)

Not currently recruiting at 1 trial location

Overseen By Guylaine Marcotte

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Must not be taking: 5+ antihypertensives

Disqualifiers: Recent kidney injury, Heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether targeting blood pressure using a central BP device benefits people with advanced chronic kidney disease (CKD) more than the traditional arm cuff method. Researchers aim to determine if central BP targeting can reduce the risk of heart and kidney problems. The trial includes two groups: one using the new central BP device and the other using the standard arm cuff, both targeting a systolic BP (the top number) under 130 mmHg. Suitable participants have CKD with a specific level of kidney function and blood pressure between 120 and 160 mmHg. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance future treatment options for CKD patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that decisions about blood pressure and kidney disease management, including medication changes, will be made by your attending Nephrologist.

What prior data suggests that central blood pressure targeting is safe for chronic kidney disease patients?

Research has shown that measuring blood pressure closer to the heart, known as central blood pressure, might be more effective for managing high blood pressure, especially in individuals with advanced chronic kidney disease (CKD). Central blood pressure provides a clearer picture of the pressure affecting the heart and vital organs like the brain and kidneys.

Although this method is still under investigation, early results suggest it could be a safe alternative to traditional arm cuff blood pressure measurements. Current studies are examining whether focusing on central blood pressure can reduce health risks without causing issues like sudden kidney problems or dangerous drops in blood pressure.

Specific information on any negative effects related to central blood pressure targeting is not yet available. However, the trial's existence indicates sufficient early evidence to consider it safe for testing in individuals. This trial aims to confirm its safety and effectiveness to determine if managing blood pressure this way is better for those with CKD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores targeting blood pressure in a new way for people with chronic kidney disease (CKD). Unlike the standard approach that focuses on brachial blood pressure (the pressure in the arm), this trial investigates targeting central blood pressure, which is the pressure closer to the heart. This could potentially provide a more accurate reflection of the stress faced by central organs, possibly leading to better outcomes for kidney health. By comparing these two approaches, researchers hope to discover whether targeting central blood pressure can offer better protection against kidney damage in CKD patients.

What evidence suggests that targeting central blood pressure could be effective for chronic kidney disease?

Research has shown that central blood pressure, the pressure in the large arteries near the heart, might predict kidney and heart problems in chronic kidney disease (CKD) patients better than the usual arm blood pressure. This trial will compare two approaches: one group will aim for a central blood pressure target, while another group will target brachial blood pressure, the standard of care. One study found that controlling central blood pressure can help slow CKD progression by reducing inflammation and stress in the kidneys. Another study showed that lowering blood pressure to specific levels improved kidney health, indicating that precise control of central blood pressure is beneficial. Many CKD patients have higher blood pressure than recommended, highlighting the need for better management. These findings suggest that focusing on central blood pressure could more effectively manage high blood pressure in CKD patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Remi Goupil, MD MSc

Principal Investigator

Hôpital Sacré-Coeur de Montréal

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced chronic kidney disease (CKD stages 4 and 5) who have an eGFR <30 mL/min/1.73m2 and a systolic blood pressure between 120-160 mmHg. It's not for those on more than four blood pressure meds, recently hospitalized for heart issues or falls, or likely to die within six months.

Inclusion Criteria

I am over 18 years old.

Your blood pressure is between 120 and 160 when measured in the doctor's office using an automated blood pressure machine.

My kidney function is low, with an eGFR below 30.

Exclusion Criteria

I am not willing to change my blood pressure medication.

I cannot give consent because of cognitive issues.

I was hospitalized due to a fall in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either a central systolic BP target or brachial systolic BP target and treated with anti-hypertensive drugs

12 months

Regular visits as per nephrologist's discretion

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluation of aortic stiffness and cardiovascular outcomes

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Central vs brachial systolic blood pressure targeting

Trial Overview The CENTRAL-CKD trial tests if targeting central blood pressure rather than the usual arm cuff measurement can better manage high blood pressure in CKD patients. Participants are randomly assigned to one of two groups: one aiming for a central BP target under 130 mmHg, the other sticking to standard brachial BP targets.

How Is the Trial Designed?

Group I: Central BP target Experimental Treatment 1 Intervention

Participants randomized to central BP target will be treated with anti-hypertensive agents to achieve a clinic central SBP \< 130 mmHg.

Group II: Brachial BP target (standard of care) Active Control 1 Intervention

Participants randomized to a brachial BP target will be treated with anti-hypertensive drugs to achieve a clinic brachial SBP \<130 mmHg.

Who Is Running the Clinical Trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Lead Sponsor

Trials

17

Recruited

4,600+

Published Research Related to This Trial

In a study of 2875 patients with chronic kidney disease (CKD) followed for an average of 5.5 years, both elevated brachial and central blood pressure (BP) measurements were linked to a higher risk of cardiovascular disease outcomes.

However, measuring central BP did not provide additional predictive value for cardiovascular outcomes or mortality compared to traditional brachial BP measurements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Central Blood Pressure and Cardiovascular Outcomes in Chronic Kidney Disease. Rahman, M., Hsu, JY., Desai, N., et al.[2023]

This pilot trial involving 116 adults with advanced chronic kidney disease (CKD G4-5) aims to assess the feasibility and efficacy of managing hypertension using central blood pressure measurements instead of traditional brachial cuff measurements, which may be unreliable in this population.

The study will evaluate the impact of targeting central BP on cardiovascular health and kidney function over 12 months, with primary outcomes including changes in pulse wave velocity and other health metrics, potentially leading to a larger trial in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol. Goupil, R., Nadeau-Fredette, AC., Prasad, B., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4707173/

Central blood pressure and chronic kidney disease - PMC Any elevation in central blood pressure accelerates CKD progression. In the kidney, interstitial inflammation induces oxidative stress to handle proteinuria.

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/JAHA.123.031742

Representation of Real‐World Adults With Chronic Kidney ... We estimate that 4 out of 5 adults with CKD and hypertension have a BP above the 2021 KDIGO guideline‐recommended target. Yet, these trials were ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925000531

Improving Blood Pressure in High-Risk Patients With CKD ... Among patients with CKD linked to nephrology care at our institution, we found that 35% met the recommended BP target of < 130/80 mm Hg using office BP ...

5. academic.oup.com academic.oup.com/ndt/article/38/12/2694/7207411

Hypertension in chronic kidney disease—treatment standard ... In this article, we review the current standards of treatment and discuss novel developments in pathophysiology, diagnosis, outcome prediction and management ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10164859/

a pragmatic RAndomized triaL in advanced Chronic Kidney ... This is the first trial to evaluate the feasibility and efficacy of using central BP to manage hypertension in advanced CKD, paving the way to a future large- ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05163158

CENtral Blood Pressure Targeting: a Pragmatic ... In no other condition than advanced chronic kidney disease (CKD) is BP control as important, since undertreatment is associated with adverse CV events and ...

8. 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.

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

The effect of different levels of systolic blood pressure ... For patients over 65 years old, the risks of outcomes were increased when SBP < 120 mmHg. The lowest HR of high or very high risk of CKD for ...