Overview

Acute Effects of Cinacalcet on Arterial Stiffness and Ventricular Function in Hemodialysis Patients

Status:
Completed
Trial end date:
2014-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Laval University
Collaborator:
Amgen
Treatments:
Cinacalcet
Cinacalcet Hydrochloride
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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