Kidney Failure, Secondary Hyperparathyroidism, Vascular Diseases
Conditions
Keywords
chronic kidney disease, peritoneal dialysis, secondary hyperparathyroidism, parathyroidectomy, vascular calcification, cinacalcet
Brief summary
This is a pilot, prospective randomized controlled study with the primary objective to evaluate and compare medical treatment of severe SHPT, namely oral cinacalcet versus surgical treatment, that is, parathyroidectomy with forearm autografting, on the progression of coronary artery and valvular calcification and left ventricular mass index in endstage renal disease patients receiving peritoneal dialysis over 12 months. The change in arterial stiffening, left ventricular volume, aortic valve calcium score and bone mineral density, nutritional status and biochemical parameters, quality of life measures will be evaluated as secondary objectives of this study.
Detailed description
Patients with severe secondary hyperparathyroidism (SHPT) are frequently complicated with vascular calcification. There is some suggestion that subtotal parathyroidectomy may reduce or stabilize vascular calcium scores in dialysis patients. Experimental data suggests that SHPT plays an important role in mediating uraemic arterial disease and that parathyroidectomy largely prevented the development of calcification. Cinacalcet has emerged as a novel therapy for the treatment of SHPT and has been shown to reduce the need for surgical parathyroidectomy. However, their effects on vascular, cardiac, bone and nutrition status have not been evaluated and compared with parathyroidectomy.
Interventions
DRUGCinacalcet
oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily
PROCEDURESurgical total parathyroidectomy with forearm autografting
Surgical total parathyroidectomy with forearm autografting will be performed
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cinacalcet medical treatment versus total parathyroidectomy with forearm autografting surgical treatment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. ESRD patients on long-term peritoneal dialysis treatment, with elevated intact parathyroid hormone (iPTH) levels \> 800pg/mL. 2. Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan. 3. Patients with age between 18 - 75 years.
Exclusion criteria
1. Patients with background valvular heart disease 2. Patients who are unfit for general anaesthesia 3. Patients with acute myocardial infarction within recent two months 4. Patients with poor general condition 5. Patients with plans for living related kidney transplant within 1 year 6. Patients with previous history of parathyroidectomy 7. Patients with underlying malignancy 8. Patients with hepatic dysfunction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in coronary artery calcium score | 52 weeks | Change in coronary artery calcium score |
| change in left ventricular mass index | 52 weeks | change in left ventricular mass index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in aortic valve and mitral valve calcium score | 52 weeks | Change in aortic valve and mitral valve calcium score |
| change in augmentation index and heart rate adjusted augmentation index | over 52 weeks | change in augmentation index and heart rate adjusted augmentation index |
| change in bone mineral density at forearm, spine and femur | 52 weeks | change in bone mineral density at forearm, spine and femur |
| Quality of Life (QOL) scores | 52 weeks | Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores) |
| change in resting energy expenditure | 24 and 52 weeks | Change in resting energy expenditure |
| change in lean muscle mass | 52 weeks | Change in lean muscle mass |
| change in handgrip strength | 24 and 52 weeks | Change in handgrip strength |
| Change in subjective global assessment | 24 and 52 weeks | Change in subjective global assessment |
| change in left ventricular volume and ejection fraction | 52 weeks | change in left ventricular volume and ejection fraction |
| change in intact parathyroid hormone (iPTH) level | 52 weeks | Change in biochemical parameter Parathyroid hormone |
| Change in alkaline phosphatase | over 52 weeks | Change in biochemical parameter alkaline phosphatase |
| change in serum albumin | over 52 weeks | CHange in biochemical parameter serum albumin |
| change in lymphocyte count | over 52 weeks | change in lymphocyte count |
| change in lipid profile | over 52 weeks | change in lipid profile |
| change in systolic and diastolic blood pressure | over 52 weeks | change in systolic and diastolic blood pressure |
| change in subendocardial viability ratio | over 52 weeks | change in subendocardial viability ratio |
| Change in serum calcium and phosphorus | over 52 weeks | Change in biochemical parameter Serum calcium and phosphorus |
| Change in aortic pulse wave velocity | 24 and 52 weeks | Change in aortic pulse wave velocity |
Countries
Hong Kong
Outcome results
None listed