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CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A
Rémi Goupil1, Annie-Claire Nadeau-Fredette2, Bhanu Prasad3
1Hopital du Sacré-Coeur de Montréal, Université de Montréal, QC, Canada.
Insights
This pilot trial assessed targeting central blood pressure (BP) versus brachial BP in advanced chronic kidney disease (CKD) patients. Results will inform future large-scale studies on hypertension management in high-risk CKD populations.
Area of Science:
- Cardiovascular Medicine
- Nephrology
- Clinical Trials
Background:
- Emerging data suggest central blood pressure (BP) is a better predictor of cardiovascular and kidney events than brachial BP.
- Patients with advanced chronic kidney disease (CKD) have high cardiovascular risk and potentially unreliable brachial BP measurements due to arterial stiffness.
- Central BP monitoring may offer significant benefits for hypertension management in this vulnerable population.
Purpose of the Study:
- To evaluate the feasibility and efficacy of targeting central BP compared to brachial BP in patients with advanced CKD (G4-5).
- To assess the potential of central BP monitoring to improve hypertension management and clinical outcomes in CKD patients.
Main Methods:
- A pragmatic, multicentre, double-blinded, randomized controlled pilot trial involving 116 adults with CKD G4-5.
- Participants were randomized to a central or brachial cuff systolic BP target (< 130 mm Hg) measured by a validated central BP device.
- The study duration was 12 months with regular follow-up visits, assessing feasibility, carotid-femoral pulse wave velocity, eGFR decline, and major adverse events.
Main Results:
- Primary feasibility outcomes assessed the potential for a large-scale trial.
- Primary efficacy endpoint was carotid-femoral pulse wave velocity at 12 months.
- Secondary outcomes included eGFR decline, albuminuria, BP drug usage, quality of life, major adverse cardiovascular events, CKD progression, hospitalization, mortality, and safety events.
Conclusions:
- This is the first trial to investigate the feasibility and efficacy of central BP-guided hypertension management in advanced CKD.
- The findings are expected to guide the design of future large-scale randomized controlled trials in this patient population.
- The study paves the way for potentially improved cardiovascular and kidney event prediction and management in CKD.
Background:
Emerging data favor central blood pressure (BP) over brachial cuff BP to predict cardiovascular and kidney events, as central BP more closely relates to the true aortic BP. Considering that patients with advanced chronic kidney disease (CKD) are at high cardiovascular risk and can have unreliable brachial cuff BP measurements (due to high arterial stiffness), this population could benefit the most from hypertension management using central BP measurements.
Objective:
To assess the feasibility and efficacy of targeting central BP as opposed to brachial BP in patients with CKD G4-5.
Design:
Pragmatic multicentre double-blinded randomized controlled pilot trial.
Setting:
Seven large academic advanced kidney care clinics across Canada.
Patients:
A total of 116 adults with CKD G4-5 (estimated glomerular filtration rate [eGFR] < 30 mL/min) and brachial cuff systolic BP between 120 and 160 mm Hg. The key exclusion criteria are 1) ≥ 5 BP drugs, 2) recent acute kidney injury, myocardial infarction, stroke, heart failure or injurious fall, 3) previous kidney replacement therapy.
Methods:
Double-blind randomization to a central or a brachial cuff systolic BP target (both < 130 mm Hg) as measured by a validated central BP device. The study duration is 12 months with follow-up visits every 2 to 4 months, based on local practice. All other aspects of CKD management are at the discretion of the attending nephrologist.
Outcomes:
Primary Feasibility: Feasibility of a large-scale trial based on predefined components. Primary Efficacy: Carotid-femoral pulse wave velocity at 12 months. Others: Efficacy (eGFR decline, albuminuria, BP drugs, and quality of life); Events (major adverse cardiovascular events, CKD progression, hospitalization, mortality); Safety (low BP events and acute kidney injury).
Limitations:
May be challenging to distinguish whether central BP is truly different from brachial BP to the point of significantly influencing treatment decisions. Therapeutic inertia may be a barrier to successfully completing a randomized trial in a population of CKD G4-5. These 2 aspects will be evaluated in the feasibility assessment of the trial.
Conclusion:
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-scale trial.
Trial Registration:
clinicaltrials.gov (NCT05163158).
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