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

Laval University23 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Chronic Kidney Disease

Interventions

CinacalcetDRUG

One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days

PlaceboDRUG

One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Karine Marquis

Québec, Quebec, Canada

Outcomes

Primary Outcomes

Arterial stiffness

Time frame: Arterial stiffness with be measured after 1 week with placebo and after 1 week with cinacalcet

Secondary Outcomes

Ventricular function

Time frame: Ventricular function with be measured after 1 week with placebo and after 1 week with cinacalcet

Data from ClinicalTrials.gov

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