Central vs Brachial Blood Pressure Targeting for Chronic Kidney Disease
(CENTRAL-CKD Trial)

Recruiting in Palo Alto (17 mi)

Overseen byRemi Goupil, MD MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

Trial Summary

What is the purpose of this trial?Background: Emerging data favors aortic blood pressure (BP) over brachial cuff BP in predicting CV and renal complications, as this BP directly impacts the heart, brain and kidneys. In parallel, central BP measuring devices have been developed that are more accurate towards aortic BP and easy to use without training. In no other condition than advanced chronic kidney disease (CKD) is BP control as important, since undertreatment is associated with adverse CV events and progression towards end-stage kidney disease (ESKD), while overtreatment similarly leads to adverse CV events and injurious falls but also acute kidney injury which can precipitate ESKD. To this day, standard BP management relies on brachial cuff BP, which is an imprecise surrogate marker of aortic BP, more so in the advanced CKD population. Considering that these patients have a high risk of CV morbidity and mortality and is a group where brachial BP may be the least reliable, it can be beneficial to manage hypertension in this population using central BP measurements. With the development of affordable and easy to use central BP devices, routine use of central BP in hypertension would now become a reality. However, the superiority of central BP to traditional brachial cuff BP in regard to clinical outcomes will first need to be demonstrated. Objectives: To demonstrate that targeting central BP in advanced CKD patients as opposed to brachial cuff BP is feasible and results in lower arterial stiffness after 12 months of follow-up. Methods: The CENTRAL-CKD trial is an investigator-initiated prospective parallel-group 1:1 randomized double-blinded multicenter pragmatic pilot trial. Patients with CKD stages 4 and 5 (n=116) will be randomized to either a central systolic BP target \< 130 mmHg (intervention) or brachial systolic BP target \< 130 mmHg (standard care). Central and brachial BP will be concomitantly measured, with treating physicians, patients and investigators blinded towards allocation. As this trial is of a pragmatic design, all other aspects of BP and CKD management, including anti-hypertensive treatment-related decisions, diastolic BP targets, and clinical and laboratory follow-ups will be at the discretion of the attending Nephrologist. The primary outcomes include feasibility of large-scale trial using prespecified criteria and aortic stiffness (carotid-femoral pulse wave velocity) at 12 months. Other cardiovascular, renal, quality of life and safety outcomes will be evaluated. Importance: CENTRAL-CKD is designed as a pilot trial aimed at providing the framework and justification to proceed to a large-scale trial with adequate power to detect the impact of the proposed intervention on clinically important outcomes.

Eligibility Criteria

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.

+6 more

Participant Groups

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.

2Treatment groups

Experimental Treatment

Active Control

Group I: Central BP targetExperimental Treatment1 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 Control1 Intervention

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