Central vs brachial systolic blood pressure targeting for Hypertension

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hypertension+3 More
Central vs brachial systolic blood pressure targeting - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Hypertension
  • Chronic Kidney Disease (CKD)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

16 Primary · 5 Secondary · Reporting Duration: 12 months

12 months
Achieved BP target rate
Acute kidney injury (>50% increase in serum creatinine)
All-cause hospitalisation
All-cause mortality
Aortic stiffness
Cardiovascular adverse events (cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation or amputation)
Change in albuminuria
Completion rate
Daily Defined Doses of blood pressure drugs
Difference in Daily Defined Doses of blood pressure drugs
Difference in aortic stiffness
Difference in eGFR decline
Difference in eGFR slope
Divergent treatment decision rate
Feasibility
Feasibility: Achieved BP target rate
Feasibility: Completion rate
Feasibility: Divergent treatment decision rate
Feasibility: Therapeutic inertia rate
Major adverse cardiovascular adverse events (cardiovascular mortality, myocardial infarction, stroke, heart failure requiring hospitalisation, peripheral artery disease requiring revascularisation or amputation)
Progression towards kidney failure (sustained eGFR loss ≥ 40%, kidney replacement therapy initiation or death from renal failure)
Quality of life (KDQOL-SF questionnaire)
Symptomatic orthostatic hypotension, dizziness, light headedness, injurious falls, syncope or any unexpected event attributable to the intervention
Therapeutic inertia rate
eGFR decline
eGFR slope
Month 12
Feasibility: Recruitment pace
Recruitment pace
Baseline
Consent rate
Feasibility: Consent rate
Feasibility: Recruitment rate
Recruitment rate

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Brachial BP target (standard of care)
1 of 2
Central BP target
1 of 2
Active Control
Experimental Treatment

116 Total Participants · 2 Treatment Groups

Primary Treatment: Central vs brachial systolic blood pressure targeting · No Placebo Group · N/A

Central BP target
Other
Experimental Group · 1 Intervention: Central vs brachial systolic blood pressure targeting · Intervention Types: Other
Brachial BP target (standard of care)
Other
ActiveComparator Group · 1 Intervention: Central vs brachial systolic blood pressure targeting · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months

Who is running the clinical trial?

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de MontrealLead Sponsor
4 Previous Clinical Trials
3,095 Total Patients Enrolled
Remi Goupil, MD MScPrincipal InvestigatorHôpital Sacré-Coeur de Montréal

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 16th, 2021

Last Reviewed: October 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.