Spironolactone to Prevent Progression of Vascular Calcification in Peritoneal Dialysis Patients
- Conditions
- vascular calcification, peritoneal dialysiscoronary artery calcium score, peritoneal dialysis, vascular calcification, spironolactone
- Registration Number
- TCTR20221207001
- Lead Sponsor
- avamindrahiraj University Research Fund
- Brief Summary
Among peritoneal dialysis patients, spironolactone showed a potential benefit to prevent the progression of vascular calcification. Further studies with a larger population and long-term follow-up should be conducted.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
1. aged 18-80 years
2. end-stage renal disease receiving peritoneal dialysis.
(1) patients who currently receive spironolactone within 3 months
(2) persistent hyperkalemia (defined as average serum potassium >5.5 mEq/L within 3 months)
(3) persistent hypotension (defined as systolic blood pressure <90 mmHg and diastolic blood pressure <60 mmHg without other antihypertensive drugs)
(4) persistent hyperphosphatemia (defined as average serum phosphate >5.5 mg/dL within 3 months)
(5) hyperparathyroidism (defined as serum intact PTH >585 pg/mL)
(6) dialysis vintage >10 years
(7) life expectancy <1 year due to active malignancy, infection or other diseases
(8) pregnancy or lactation female
(9) post kidney transplant or kidney transplant candidate within 1 year.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method progression of coronary artery calcium scores baseline and 6 months Coronary artery calcium scores
- Secondary Outcome Measures
Name Time Method biomarker of mineral-bone disorder baseline and 6 months Laboratory including calcium, phosphorus, iPTH, osteocalcin, ALP,Safety baseline and 6 months Adverse events