CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol
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 u...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2023-05-01
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| Series: | Canadian Journal of Kidney Health and Disease |
| Online Access: | https://doi.org/10.1177/20543581231172407 |
| _version_ | 1797832451769237504 |
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| author | Rémi Goupil Annie-Claire Nadeau-Fredette Bhanu Prasad Gregory L. Hundemer Rita S. Suri William Beaubien-Souligny Mohsen Agharazii |
| author_facet | Rémi Goupil Annie-Claire Nadeau-Fredette Bhanu Prasad Gregory L. Hundemer Rita S. Suri William Beaubien-Souligny Mohsen Agharazii |
| author_sort | Rémi Goupil |
| collection | DOAJ |
| description | 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) |
| first_indexed | 2024-04-09T14:08:02Z |
| format | Article |
| id | doaj.art-cc9c3743e6e74c1cbd672f97e09b90d6 |
| institution | Directory Open Access Journal |
| issn | 2054-3581 |
| language | English |
| last_indexed | 2024-04-09T14:08:02Z |
| publishDate | 2023-05-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Canadian Journal of Kidney Health and Disease |
| spelling | doaj.art-cc9c3743e6e74c1cbd672f97e09b90d62023-05-06T19:03:46ZengSAGE PublishingCanadian Journal of Kidney Health and Disease2054-35812023-05-011010.1177/20543581231172407CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research ProtocolRémi Goupil0Annie-Claire Nadeau-Fredette1Bhanu Prasad2Gregory L. Hundemer3Rita S. Suri4William Beaubien-Souligny5Mohsen Agharazii6Hopital du Sacré-Coeur de Montréal, Université de Montréal, QC, CanadaHopital Maisonneuve-Rosemont, Université de Montréal, QC, CanadaRegina General Hospital, SK, CanadaDivision of Nephrology, Department of Medicine, The Ottawa Hospital Research Institute, University of Ottawa, ON, CanadaMcGill University Health Centre, McGill University, Montréal, QC, CanadaCentre Hospitalier de l’Université de Montréal, Université de Montréal, QC, CanadaCentre Hospitalier Universitaire de Québec, Université Laval, CanadaBackground: 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)https://doi.org/10.1177/20543581231172407 |
| spellingShingle | Rémi Goupil Annie-Claire Nadeau-Fredette Bhanu Prasad Gregory L. Hundemer Rita S. Suri William Beaubien-Souligny Mohsen Agharazii CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol Canadian Journal of Kidney Health and Disease |
| title | CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol |
| title_full | CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol |
| title_fullStr | CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol |
| title_full_unstemmed | CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol |
| title_short | CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol |
| title_sort | central blood pressure targeting a pragmatic randomized trial in advanced chronic kidney disease central ckd a clinical research protocol |
| url | https://doi.org/10.1177/20543581231172407 |
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