Prevention of the Progression of Coronary Calcification With Use of Spironolactone in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Spironolactone on the Progression of Coronary Calcification in Peritoneal Dialysis Patients

Conditions
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Coronary Artery Calcification, Vascular Calcification

Intervention / Treatment
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* Drug: Spironolactone 25Mg Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Coronary calcium score > 30 Agatston unit Peritoneal dialysis for at least 6 months Exclusion Criteria: Use of spironolactone in the last 3 months Mean serum potassium > 6 mEq/L in the last 3 months Cardiac revascularization surgeries Arrhythmias Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spironolactone group<br>Spironolactone oral tablet 25mg/day, for 12 months | Drug: Spironolactone 25Mg Tablet<br>* Patients with coronary calcium score > 30 were treated with spironolactone for 12 months<br>|
| No Intervention: Control group<br>No spironolactone use | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative progression of the coronary calcium score | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute progression of the coronary calcium score | 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. | 12 months | 
| Adverse effects of spironolactone use | 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. | 12 months | 
| 1 year change in laboratory parameters of mineral metabolism | 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. | 12 months | 
| Need for spironolactone dose reduction | In the presence of adverse effects, the dose of spironolactone was reduced from 25 to 12,5 mg per day. | 12 months | 
| Causes of discontinuation of the study | 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. | 12 months | 
| 1 year change in laboratory parameters related to inflammation. | Assess changes on serum levels of c-reactive protein, albumin and fetuin-A, through periodic blood dosages of these parameters, during follow-up. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vascular calcification, Coronary calcification, Peritoneal Dialysis, Spironolactone