Central vs Brachial Blood Pressure Targeting for Chronic Kidney Disease
(CENTRAL-CKD Trial)
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.
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 data supports the effectiveness of the treatment Central vs brachial systolic blood pressure targeting for chronic kidney disease?
Research suggests that central blood pressure (the pressure in the arteries near the heart) may be a better indicator of health outcomes than brachial blood pressure (the pressure in the arm) because it is more closely related to organ damage and cardiovascular events. This implies that targeting central blood pressure could potentially improve management of chronic kidney disease.12345
Is targeting central blood pressure safe for humans?
Current research suggests that central blood pressure targeting is generally safe, as it is closely related to true aortic blood pressure and may better predict cardiovascular and kidney events. However, more clinical trials are needed to confirm its safety and effectiveness compared to traditional brachial blood pressure targeting.678910
How does central blood pressure targeting differ from other treatments for chronic kidney disease?
Research Team
Remi Goupil, MD MSc
Principal Investigator
Hôpital Sacré-Coeur de Montréal
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either a central systolic BP target or brachial systolic BP target and treated with anti-hypertensive drugs
Follow-up
Participants are monitored for safety and effectiveness after treatment, including evaluation of aortic stiffness and cardiovascular outcomes
Treatment Details
Interventions
- Central vs brachial systolic blood pressure targeting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Lead Sponsor