Prevention of the Progression of Coronary Calcification With Use of Spironolactone in Peritoneal Dialysis Patients
- Conditions
- Coronary Artery CalcificationVascular Calcification
- Interventions
- Registration Number
- NCT03314493
- Lead Sponsor
- Professor Fernando Figueira Integral Medicine Institute
- Brief Summary
Vascular calcification is a frequent complication in dialysis patients and is strongly associated with mortality. Its pathogenesis is complex and involves a series of markers that act on the vascular microenvironment. There is evidence that aldosterone is one of the biomarkers and may have a role in osteoinductive pathways.The aim of this study was to evaluate the effect of spironolactone, an inhibitor of mineralocorticoid receptor, in the progression of coronary calcification in patients undergoing peritoneal dialysis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- Coronary calcium score > 30 Agatston unit
- Peritoneal dialysis for at least 6 months
- Use of spironolactone in the last 3 months
- Mean serum potassium > 6 mEq/L in the last 3 months
- Cardiac revascularization surgeries
- Arrhythmias
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Spironolactone group Spironolactone 25Mg Tablet Spironolactone oral tablet 25mg/day, for 12 months
- Primary Outcome Measures
Name Time Method Relative progression of the coronary calcium score 12 months Percentage change in coronary calcium score from baseline to end of study. Coronary calcium score detected using multi-detector computed tomography and expressed in Agatston units.
- Secondary Outcome Measures
Name Time Method Absolute progression of the coronary calcium score 12 months To evaluate the absolute progression of the coronary calcium score, defined as the difference between the final score and the baseline score. Coronary calcium score detected using multi-detector computed tomography and expressed in Agatston units.
Adverse effects of spironolactone use 12 months During follow-up, all patients were assessed monthly to evaluate the frequency of hyperpotassemia (serum potassium \> 6mEq/L), hypotension (systolic blood pressure \< 100 mmHg) and/or diastolic blood pressure \< 60 mmHg) and gynecomastia defined as breast augmentation, painful or not.
1 year change in laboratory parameters of mineral metabolism 12 months Assess changes in serum levels of total calcium, phosphorus, alkaline phosphatase, 25(OH) vitamina D and intact parathyroid hormone, through periodic blood dosages of these parameters, during follow-up.
Need for spironolactone dose reduction 12 months In the presence of adverse effects, the dose of spironolactone was reduced from 25 to 12,5 mg per day.
Causes of discontinuation of the study 12 months Severe hyperpotassemia defined as serum potassium\>7mEq/L; lack of improvement in the adverse effects of spironolactone with a dose reduction of 12,5 mg/day, ie, persistence of breasts enlargement, hypotension and hyperpotassemia (serum potassium \< 6mEq/L); discontinuation of peritoneal dialysis due to renal transplantation or the need for hemodialysis transfer; withdrawal of consent at any time; and death were considered as causes for discontinuation of the study. For the evaluation of this outcome, the patients were submitted to medical visit and biochemical measures monthly.
1 year change in laboratory parameters related to inflammation. 12 months Assess changes on serum levels of c-reactive protein, albumin and fetuin-A, through periodic blood dosages of these parameters, during follow-up.
Trial Locations
- Locations (1)
Instituto de Medicina Integral Prof. Fernando Figueira
🇧🇷Recife, Pernambuco, Brazil