- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05163158
CENtral Blood Pressure Targeting: A Pragmatic RAndomized Pilot triaL in Advanced Chronic Kidney Disease (CENTRAL-CKD)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Guylaine Marcotte
- Phone Number: 3182 1(514)338-2222
- Email: guylaine.marcotte@cnmtl.gouv.qc.ca
Study Locations
-
-
Quebec
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Montréal, Quebec, Canada, H4J1C5
- Recruiting
- Hopital Du Sacre-Coeur De Montreal
-
Principal Investigator:
- Remi Goupil, MD MSc
-
Contact:
- Guylaine Marcotte
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Over 18 years of age;
- eGFR <30 mL/min/1.73m2 as determined by the CKD-EPI equation (within 30 days of screening);
- Office brachial cuff systolic blood pressure between 120 and 160 mmHg (using automated office blood pressure).
Exclusion Criteria:
- Already taking 5 or more anti-hypertensive medications (any class)
- Unwillingness to change anti-hypertensive medication by the attending Nephrologist or patient
- Recent acute kidney injury (>50% increase in serum creatinine in preceding 30 days)
- Previous kidney replacement therapy (kidney transplant, hemodialysis or peritoneal dialysis)
- Recent myocardial infarction, stroke, heart failure (in preceding 30 days)
- Recent injurious fall requiring hospitalisation (in preceding 30 days)
- Concomitant major illness / comorbidity that may result in death in the next 6 months
- Participation in another study that is likely to affect BP levels
- Inability to provide consent due to cognitive impairment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Central BP target
Participants randomized to central BP target will be treated with anti-hypertensive agents to achieve a clinic central SBP < 130 mmHg.
|
Participants will be randomized to either a central BP target (intervention) or a brachial BP target (standard care).
For each group, the source of the BP (central or brachial) will be blinded and only the BP values will be provided to the attending Nephrologist.
In both cases, the target SBP will be <130 mmHg.
|
Active Comparator: Brachial BP target (standard of care)
Participants randomized to a brachial BP target will be treated with anti-hypertensive drugs to achieve a clinic brachial SBP <130 mmHg.
|
Participants will be randomized to either a central BP target (intervention) or a brachial BP target (standard care).
For each group, the source of the BP (central or brachial) will be blinded and only the BP values will be provided to the attending Nephrologist.
In both cases, the target SBP will be <130 mmHg.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility: Consent rate
Time Frame: Baseline
|
Proportion of participants who provide consent relative to the number approached for participation. Feasibility criteria (No / Probable / Yes): <30% / 30-60% / >60% |
Baseline
|
Feasibility: Recruitment rate
Time Frame: Baseline
|
Proportion of randomized participants relative to the number of screened participants. Feasibility criteria (No / Probable / Yes): <40% / 40-80% / >80% |
Baseline
|
Feasibility: Achieved BP target rate
Time Frame: 12 months
|
Proportion of randomized participants who achieve BP target at 12 months Feasibility criteria (No / Probable / Yes): <30% / 30-60% / >60%
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12 months
|
Feasibility: Completion rate
Time Frame: 12 months
|
Proportion of randomized participants who complete the trial Feasibility criteria (No / Probable / Yes): <40% / 40-80% / >80%
|
12 months
|
Feasibility: Recruitment pace
Time Frame: 12 months after activation of last site
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Number of participants recruited after 24 months of activation for all sites Feasibility criteria (No / Probable / Yes): <54 / 54-81 / >81
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12 months after activation of last site
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Feasibility: Divergent treatment decision rate
Time Frame: 12 months
|
Proportion of divergent treatment decision based on central BP compared to brachial BP Feasibility criteria (No / Probable / Yes): <10% / 10-30% / >30%
|
12 months
|
Feasibility: Therapeutic inertia rate
Time Frame: 12 months
|
Proportion of therapeutic inertia Feasibility criteria (No / Probable / Yes): >60% / 60-30% / <30%
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12 months
|
Difference in aortic stiffness
Time Frame: 12 months
|
Carotid-femoral pulse wave velocity
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12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in eGFR decline
Time Frame: 12 months
|
12 months
|
|
Change in albuminuria
Time Frame: 12 months
|
12 months
|
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Difference in Daily Defined Doses of blood pressure drugs
Time Frame: 12 months
|
12 months
|
|
Quality of life (KDQOL-SF questionnaire)
Time Frame: 12 months
|
Score 0 to 100.
Higher score represents better quality of life
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All-cause mortality
Time Frame: 12 months
|
12 months
|
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Progression towards kidney failure (sustained eGFR loss ≥ 40%, kidney replacement therapy initiation or death from renal failure)
Time Frame: 12 months
|
12 months
|
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Major adverse cardiovascular adverse events (cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation or amputation)
Time Frame: 12 months
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Composite and individuals outcomes
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12 months
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All-cause hospitalisation
Time Frame: 12 months
|
12 months
|
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Acute kidney injury (>50% increase in serum creatinine)
Time Frame: 12 months
|
12 months
|
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Symptomatic orthostatic hypotension, dizziness, light headedness, injurious falls, syncope or any unexpected event attributable to the intervention
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Remi Goupil, MD MSc, Hôpital Sacré-Coeur de Montréal
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Urologic Diseases
- Disease Attributes
- Renal Insufficiency
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Hypertension
- Kidney Diseases
- Renal Insufficiency, Chronic
Other Study ID Numbers
- CENTRAL-CKD Protocol Version 1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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