MedPath

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

Phase 4
Completed
Conditions
Chronic Kidney Disease
Interventions
Drug: Placebo
Registration Number
NCT01250405
Lead Sponsor
Laval University
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
23
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
CinacalcetCinacalcet-
Primary Outcome Measures
NameTimeMethod
Arterial stiffnessArterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet
Secondary Outcome Measures
NameTimeMethod
Ventricular functionVentricular function with be measured after 1 week with placebo and after 1 week with cinacalcet

Trial Locations

Locations (1)

Karine Marquis

🇨🇦

Québec, Quebec, Canada

© Copyright 2025. All Rights Reserved by MedPath