vascular calcification, peritoneal dialysis coronary artery calcium score, peritoneal dialysis, vascular calcification, spironolactone
Conditions
Interventions
spironolactone 25 mg daily for 6 months,Placebo daily for 6 months
Experimental Drug,Placebo Comparator Drug
Sponsors
Navamindrahiraj University Research Fund
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. aged 18-80 years 2. end-stage renal disease receiving peritoneal dialysis.
Exclusion criteria
Exclusion criteria: (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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression of coronary artery calcium scores baseline and 6 months Coronary artery calcium scores | — |
Secondary
| Measure | Time frame |
|---|---|
| biomarker of mineral-bone disorder baseline and 6 months Laboratory including calcium, phosphorus, iPTH, osteocalcin, ALP,Safety baseline and 6 months Adverse events | — |
Countries
Thailand
Contacts
Public ContactPeerapat Thanapongsatorn
Central Chest Institute of Thailand
Outcome results
None listed