Queen Mary Hospital and Tung Wah Hospital
Hong Kong, 0000
NCT Number: NCT01447368
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Hong Kong, 0000
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Other names: Regpara
Surgical total parathyroidectomy with forearm autografting will be performed
Time frame: 52 weeks
Change in coronary artery calcium score
Time frame: 52 weeks
change in left ventricular mass index
Time frame: 52 weeks
change in left ventricular volume and ejection fraction
Time frame: 24 and 52 weeks
Change in aortic pulse wave velocity
Time frame: 52 weeks
Change in aortic valve and mitral valve calcium score
Time frame: over 52 weeks
change in augmentation index and heart rate adjusted augmentation index
Time frame: 52 weeks
change in bone mineral density at forearm, spine and femur
Time frame: 52 weeks
Kidney Disease Outcome Quality Initiatives (KDOQI QOL domain scores)
Time frame: 24 and 52 weeks
Change in resting energy expenditure
Time frame: 52 weeks
Change in lean muscle mass
Time frame: 24 and 52 weeks
Change in handgrip strength
Time frame: 24 and 52 weeks
Change in subjective global assessment
Time frame: over 52 weeks
Change in biochemical parameter Serum calcium and phosphorus
Time frame: 52 weeks
Change in biochemical parameter Parathyroid hormone
Time frame: over 52 weeks
Change in biochemical parameter alkaline phosphatase
Time frame: over 52 weeks
CHange in biochemical parameter serum albumin
Time frame: over 52 weeks
change in lymphocyte count
Time frame: over 52 weeks
change in lipid profile
Time frame: over 52 weeks
change in systolic and diastolic blood pressure
Time frame: over 52 weeks
change in subendocardial viability ratio
The University of Hong Kong
Other
Comparison of Medical Therapy (Oral Cinacalcet) Versus Surgical Therapy (Total Parathyroidectomy) on Vascular/Valvular Calcification in Chronic Peritoneal Dialysis Patients With Secondary Hyperparathyroidism - A Pilot Randomized Study
Acronym: PROCEED
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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