Chronic Kidney DiseasesCENTRAL-CKDNCT05163158
CENtral Blood Pressure Targeting: A Pragmatic RAndomized Pilot triaL in Advanced Chronic Kidney Disease
A study testing Central vs brachial systolic blood pressure targeting in people with Chronic Kidney Diseases and Hypertension, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension
- What is being tested?
- Central vs brachial systolic blood pressure targeting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteCanada
- Study dates
- 24 May 2022to 30 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Central vs brachial systolic blood pressure targeting
- Keywords
- Central blood pressure, Central hypertension, Chronic kidney disease, Hypertension, Arterial stiffness
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central vs brachial systolic blood pressure targetingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Central vs brachial systolic blood pressure targeting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: Baseline
Feasibility: Recruitment rate
Proportion of randomized participants relative to the number of screened participants.
Feasibility criteria (No / Probable / Yes): <40% / 40-80% / >80%
Measured: 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%
Measured: 12 months
Feasibility: Completion rate
Proportion of randomized participants who complete the trial Feasibility criteria (No / Probable / Yes): <40% / 40-80% / >80%
Measured: 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
Measured: 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%
Measured: 12 months
Feasibility: Therapeutic inertia rate
Proportion of therapeutic inertia Feasibility criteria (No / Probable / Yes): >60% / 60-30% / <30%
Measured: 12 months
Difference in aortic stiffness
Carotid-femoral pulse wave velocity
Measured: 12 months
Secondary outcomes (4)
Difference in eGFR decline
Measured: 12 months
Change in albuminuria
Measured: 12 months
Difference in Daily Defined Doses of blood pressure drugs
Measured: 12 months
Quality of life (KDQOL-SF questionnaire)
Score 0 to 100. Higher score represents better quality of life
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2021
- Study start24 May 2022
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Remi Goupil, MD MSc, Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
- Investigators
- Remi Goupil, MD MSc, Principal investigator, Hôpital Sacré-Coeur de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05163158
- Sponsor's protocol ID
- CENTRAL-CKD Protocol Version 1
- Acronym
- CENTRAL-CKD
- Status last verified
- Mar 2026
- First submitted
- 6 Dec 2021
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37168686
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CENtral Blood Pressure Targeting: A Pragmatic RAndomized Pilot triaL in Advanced Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT05163158
- Acronym / sponsor ID
- CENTRAL-CKD / CENTRAL-CKD Protocol Version 1
- Conditions
- Chronic Kidney Diseases, Hypertension
- Keywords
- Central blood pressure, Central hypertension, Chronic kidney disease, Hypertension, Arterial stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 20 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central BP target | Experimental | Other: Central vs brachial systolic blood pressure targetingParticipants randomized to central BP target will be treated with anti-hypertensive agents to achieve a clinic central SBP < 130 mmHg. |
| Brachial BP target (standard of care) | Active comparator | Other: Central vs brachial systolic blood pressure targetingParticipants randomized to a brachial BP target will be treated with anti-hypertensive drugs to achieve a clinic brachial SBP <130 mmHg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Central vs brachial systolic blood pressure targetingParticipants 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. | Other | Brachial BP target (standard of care), Central BP target |
Primary outcome
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%
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%
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%
Feasibility: Completion rate
Time frame: 12 months
Proportion of randomized participants who complete the trial Feasibility criteria (No / Probable / Yes): <40% / 40-80% / >80%
Feasibility: Recruitment pace
Time frame: 12 months after activation of last site
Number of participants recruited after 24 months of activation for all sites Feasibility criteria (No / Probable / Yes): <54 / 54-81 / >81
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%
Feasibility: Therapeutic inertia rate
Time frame: 12 months
Proportion of therapeutic inertia Feasibility criteria (No / Probable / Yes): >60% / 60-30% / <30%
Difference in aortic stiffness
Time frame: 12 months
Carotid-femoral pulse wave velocity
4 secondary outcomes
Difference in eGFR decline
Time frame: 12 months
Change in albuminuria
Time frame: 12 months
Difference in Daily Defined Doses of blood pressure drugs
Time frame: 12 months
Quality of life (KDQOL-SF questionnaire)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 37168686Goupil 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Remi Goupil, MD MSc principal investigator
Hôpital Sacré-Coeur de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Central vs brachial systolic blood pressure targeting in people with Chronic Kidney Diseases and Hypertension, run by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Consent rate (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05163158, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.