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Central vs Brachial Blood Pressure Targeting for Chronic Kidney Disease (CENTRAL-CKD Trial)
N/A
Waitlist Available
Led By Remi Goupil, MD MSc
Research Sponsored by Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Over 18 years of age
Be older than 18 years old
Must not have
Unwillingness to change anti-hypertensive medication by the attending Nephrologist or patient
Inability to provide consent due to cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is designed to compare the feasibility and effectiveness of targeting central BP in advanced CKD patients as opposed to brachial cuff BP.
Who is the study for?
This trial is for adults over 18 with advanced chronic kidney disease (CKD stages 4 and 5) who have an eGFR <30 mL/min/1.73m2 and a systolic blood pressure between 120-160 mmHg. It's not for those on more than four blood pressure meds, recently hospitalized for heart issues or falls, or likely to die within six months.
What is being tested?
The CENTRAL-CKD trial tests if targeting central blood pressure rather than the usual arm cuff measurement can better manage high blood pressure in CKD patients. Participants are randomly assigned to one of two groups: one aiming for a central BP target under 130 mmHg, the other sticking to standard brachial BP targets.
What are the potential side effects?
Since this study focuses on measuring techniques rather than new medications, side effects may be related to changes in existing hypertension treatment regimens as directed by doctors but are not directly caused by the intervention itself.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am over 18 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not willing to change my blood pressure medication.
Select...
I cannot give consent because of cognitive issues.
Select...
My kidney function has worsened significantly in the last month.
Select...
I am currently taking 5 or more medications for high blood pressure.
Select...
I have had a kidney transplant or been on dialysis.
Select...
I do not have any major illness that could lead to death within 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Difference in aortic stiffness
Feasibility: Achieved BP target rate
Feasibility: Completion rate
+5 moreSecondary study objectives
Quality of life (KDQOL-SF questionnaire)
Other study objectives
Major adverse cardiovascular adverse events (cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation or amputation)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Central BP targetExperimental Treatment1 Intervention
Participants randomized to central BP target will be treated with anti-hypertensive agents to achieve a clinic central SBP \< 130 mmHg.
Group II: Brachial BP target (standard of care)Active Control1 Intervention
Participants randomized to a brachial BP target will be treated with anti-hypertensive drugs to achieve a clinic brachial SBP \<130 mmHg.
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Who is running the clinical trial?
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealLead Sponsor
16 Previous Clinical Trials
4,660 Total Patients Enrolled
Remi Goupil, MD MScPrincipal InvestigatorHôpital Sacré-Coeur de Montréal
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not willing to change my blood pressure medication.I cannot give consent because of cognitive issues.I was hospitalized due to a fall in the last 30 days.You are currently involved in another study that may affect your blood pressure levels.My kidney function has worsened significantly in the last month.I have not had a heart attack, stroke, or heart failure in the last 30 days.I am currently taking 5 or more medications for high blood pressure.I have had a kidney transplant or been on dialysis.I am over 18 years old.I do not have any major illness that could lead to death within 6 months.Your blood pressure is between 120 and 160 when measured in the doctor's office using an automated blood pressure machine.My kidney function is low, with an eGFR below 30.
Research Study Groups:
This trial has the following groups:- Group 1: Brachial BP target (standard of care)
- Group 2: Central BP target
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.