A Phase 3 interventional study of Spironolactone 25Mg Tablet in Coronary Artery Calcification and Vascular Calcification, sponsored by Professor Fernando Figueira Integral Medicine Institute. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-19.
Sponsored by Professor Fernando Figueira Integral Medicine Institute · Phase 3, Interventional, and Prevention
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.
82 studies on the registry are indexed under Vascular Calcification; 17 are open to participants now.
This study's enrollment of 33 is below the median of 64 across 56 interventional studies indexed under Vascular Calcification.
Browse Vascular Calcification studies →Professor Fernando Figueira Integral Medicine Institute is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Spironolactone oral tablet 25mg/day, for 12 months
Drug: Spironolactone 25Mg Tablet
No spironolactone use
Patients with coronary calcium score \> 30 were treated with spironolactone for 12 months
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Ran from Nov 2014 to primary completion in Nov 2016, 24 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Spironolactone
Professor Fernando Figueira Integral Medicine Institute