Arterial Stiffness, Hyperparathyroidism
Conditions
Keywords
hyperparathyroidism, pulse wave velocity, end-stage renal disease, arterial stiffness
Brief summary
Active parathyroid glands among renal dialysis patients contribute to calcified and hardened blood vessels. Such damage to the blood vessels, in turn, takes a significant toll in terms of cardiovascular disease. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. The investigators designed an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
Detailed description
Mineral metabolism disturbance and hyperparathyroidism contribute to arterial stiffness and vascular calcification. The vascular damage, in turn, contributes to significant cardiovascular morbidity and mortality of end-stage renal disease patients. Calcimimetics has been suggested to lower the risk of vascular calcification. Role of cinacalcet was demonstrated in animal model but human data are lacking. We design an open label pilot study to evaluate the effect of cinacalcet in 20 peritoneal dialysis patients with inadequately controlled secondary hyperparathyroidism despite standard treatment. The primary outcome is the aortic pulse wave velocity at 26 and 52 months after cinacalcet treatment.
Interventions
DRUGCinacalcet
starting with 25 mg daily dose with titration, maximum dose 100 mg daily
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* plasma parathyroid hormone level of at least 300 pg/ml (31.8 pmol/L) * aged 18 or older on peritoneal dialysis for at least three months * willingness to give written consent and comply with the study protocol
Exclusion criteria
* evidence of cancer, active infection or diseases with limited life expectancy * diseases known to cause hypercalcaemia * adjusted serum calcium level below 2.1 mmol/L (8.4 mg/dL) after correction for albumin * participation in another interventional study within last 30 days of randomization * history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the study procedures * patients receiving drugs with a narrow therapeutic index and metabolized by cytochrome P-450 2D6 (which is inhibited by cinacalcet): flecainide, thioridazine and most tricyclic antidepressants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic pulse wave velocity after the cinacalcet treatment | change in aortic pulse wave velocity at 52 weeks from baseline | as before |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in the values for parathyroid hormone levels | within one year of treatment with cinacalcet | Blood samples will be stored before and after treatment with cinacalcet for further analysis. |
| Change in calcium levels | within one year of treatment with cinacalcet | as before |
| Aortic pulse wave velocity after the cinacalcet treatment | change in aortic pulse wave velocity at 26 weeks from baseline | as stated in the description of Primary Outcome Measure |
| Change in phosphorus levels | within one year of cinacalcet treatment | as before |
| Change in calcium-phosphorus product | within one year of cinacalcet treatment | as before |
Countries
Hong Kong
Outcome results
None listed