Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients
ECIRA
1 other identifier
interventional
23
1 country
1
Brief Summary
The primary objective is to determine whether reduction of serum calcium concentration by cinacalcet leads to reduction of mean blood pressure adjusted c-fPWV. The secondary objectives are to study the effects of calcium reduction on 1) carotid-radial PWV (c-rPWV), 2) common carotid artery (CCA) biomechanics, 3) pulse wave profile and cardiac function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 26, 2010
CompletedFirst Posted
Study publicly available on registry
November 30, 2010
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedApril 7, 2014
April 1, 2014
1.9 years
November 26, 2010
April 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Arterial stiffness
Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet
Secondary Outcomes (1)
Ventricular function
Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet
Study Arms (2)
Cinacalcet
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days
Eligibility Criteria
You may qualify if:
- chronic (\> 3 months) hemodialysis population of \> 18 years old
- PTH \> 300 ng/L
- corrected Ca \> 2.10 mmol/L
- stable hypertensive drugs (\> 1 month)
- stable doses of phosphate binders and dialysis calcium concentration
- palpable femoral pulse
- systolic BP of 90-180 mmHg
- expected survival of \> 6 months
You may not qualify if:
- hemodialysis \> 3 years
- acute infection
- history of myocardial infarction or stroke within the past 3 months
- inability to consent
- intolerance to cinacalcet
- inadequate birth control
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Amgencollaborator
Study Sites (1)
Karine Marquis
Québec, Quebec, G1R2J6, Canada
Related Publications (1)
Poulin A, Bellemare PL, Fortier C, Mac-Way F, Desmeules S, Marquis K, Gaudreault V, Lebel M, Agharazii M. Acute effects of cinacalcet on arterial stiffness and ventricular function in hemodialysis patients: A randomized double-blinded crossover study. Medicine (Baltimore). 2017 May;96(21):e6912. doi: 10.1097/MD.0000000000006912.
PMID: 28538380DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohsen Agharazii, MD
Laval University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professionnelle de recherche
Study Record Dates
First Submitted
November 26, 2010
First Posted
November 30, 2010
Study Start
May 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
April 7, 2014
Record last verified: 2014-04