CENtral Blood Pressure Targeting: A Pragmatic RAndomized Pilot triaL in Advanced Chronic Kidney Disease

NCT05163158 | Completed

• 1 other identifier: CENTRAL-CKD Protocol Version 1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Diseases; Hypertension

Keywords

Central blood pressure; Central hypertension; Chronic kidney disease; Hypertension; Arterial stiffness

Outcome Measures

Primary Outcomes (8)

• Feasibility: Consent rate

  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

  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

  Proportion of randomized participants who achieve BP target at 12 months Feasibility criteria (No / Probable / Yes): \<30% / 30-60% / \>60%

  12 months

• Feasibility: Completion rate

  Proportion of randomized participants who complete the trial Feasibility criteria (No / Probable / Yes): \<40% / 40-80% / \>80%

  12 months

• Feasibility: Recruitment pace

  Number of participants recruited after 24 months of activation for all sites Feasibility criteria (No / Probable / Yes): \<54 / 54-81 / \>81

  12 months after activation of last site

• Feasibility: Divergent treatment decision rate

  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

  Proportion of therapeutic inertia Feasibility criteria (No / Probable / Yes): \>60% / 60-30% / \<30%

  12 months

• Difference in aortic stiffness

  Carotid-femoral pulse wave velocity

  12 months

Secondary Outcomes (4)

• Difference in eGFR decline

  12 months

• Change in albuminuria

  12 months

• Difference in Daily Defined Doses of blood pressure drugs

  12 months

• Quality of life (KDQOL-SF questionnaire)

  12 months

Other Outcomes (6)

• Progression towards kidney failure (sustained eGFR loss ≥ 40%, kidney replacement therapy initiation or death from renal failure)

  12 months

• Major adverse cardiovascular adverse events (cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation or amputation)

  12 months

• All-cause hospitalisation

  12 months

Study Arms (2)

Central BP target

EXPERIMENTAL

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

Other: Central vs brachial systolic blood pressure targeting

Brachial BP target (standard of care)

ACTIVE COMPARATOR

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

Other: Central vs brachial systolic blood pressure targeting

Interventions

Central vs brachial systolic blood pressure targeting OTHER

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.

Brachial BP target (standard of care); Central BP target

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hôpital du Sacré-Coeur de Montréal

Montreal, Quebec, H4J1C5, Canada

Location

Related Publications (1)

• Goupil R, Nadeau-Fredette AC, Prasad B, Hundemer GL, Suri RS, Beaubien-Souligny W, Agharazii M. CENtral blood pressure Targeting: a pragmatic RAndomized triaL in advanced Chronic Kidney Disease (CENTRAL-CKD): A Clinical Research Protocol. Can J Kidney Health Dis. 2023 May 6;10:20543581231172407. doi: 10.1177/20543581231172407. eCollection 2023.

  PMID: 37168686 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Remi Goupil, MD MSc

  Hôpital Sacré-Coeur de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: May 24, 2022
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

CA (1)