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| Name | Class |
|---|---|
| Federal University of São Paulo | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spironolactone group | Experimental | Spironolactone oral tablet 25mg/day, for 12 months |
|
| Control group | No Intervention | No spironolactone use |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spironolactone 25Mg Tablet | Drug | Patients with coronary calcium score > 30 were treated with spironolactone for 12 months |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Paula S Gueiros, MD | Instituto de Medicina Integral Prof. Fernando Figueira | Principal Investigator |
| Alex SR Souza, PhD | Instituto de Medicina Integral Prof. Fernando Figueira | Principal Investigator |
| Aluizio B Carvalho, PhD | Universidade Federal de São Paulo | Study Director |
| José E Gueiros, MD | Instituto de Medicina Integral Prof. Fernando Figueira | Study Chair |
| Leuridan T Cavalcante, PhD | Instituto de Medicina Integral Prof. Fernando Figueira | Study Chair |
| Dulce E Casarini, PhD | Universidade Federal de São Paulo | Study Chair |
| Marina M Cadena | Instituto de Medicina Integral Prof. Fernando Figueira | Study Chair |
| Karina T Nobrega, MD | Instituto de Medicina Integral Prof. Fernando Figueira | Study Chair |
| Eveline B Calado, MD | Instituto de Medicina Integral Prof. Fernando Figueira |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto de Medicina Integral Prof. Fernando Figueira | Recife | Pernambuco | 50070-550 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20719979 | Background | Fischer SS, Kempe DS, Leibrock CB, Rexhepaj R, Siraskar B, Boini KM, Ackermann TF, Foller M, Hocher B, Rosenblatt KP, Kuro-O M, Lang F. Hyperaldosteronism in Klotho-deficient mice. Am J Physiol Renal Physiol. 2010 Nov;299(5):F1171-7. doi: 10.1152/ajprenal.00233.2010. Epub 2010 Aug 18. | |
| 23298834 | Background |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 21, 2020 | |
| Reset | Sep 11, 2020 |
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| 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 |
| Study Chair |
| Voelkl J, Alesutan I, Leibrock CB, Quintanilla-Martinez L, Kuhn V, Feger M, Mia S, Ahmed MS, Rosenblatt KP, Kuro-O M, Lang F. Spironolactone ameliorates PIT1-dependent vascular osteoinduction in klotho-hypomorphic mice. J Clin Invest. 2013 Feb;123(2):812-22. doi: 10.1172/JCI64093. Epub 2013 Jan 9. |
| 26336165 | Background | Tatsumoto N, Yamada S, Tokumoto M, Eriguchi M, Noguchi H, Torisu K, Tsuruya K, Kitazono T. Spironolactone ameliorates arterial medial calcification in uremic rats: the role of mineralocorticoid receptor signaling in vascular calcification. Am J Physiol Renal Physiol. 2015 Dec 1;309(11):F967-79. doi: 10.1152/ajprenal.00669.2014. Epub 2015 Sep 2. |
| 12935835 | Result | Nitta K, Akiba T, Nihei H. Aldosterone blockade and vascular calcification in hemodialysis patients. Am J Med. 2003 Aug 15;115(3):250. doi: 10.1016/s0002-9343(03)00293-6. No abstract available. |
| 24184249 | Result | Matsumoto Y, Mori Y, Kageyama S, Arihara K, Sugiyama T, Ohmura H, Yakushigawa T, Sugiyama H, Shimada Y, Nojima Y, Shio N. Spironolactone reduces cardiovascular and cerebrovascular morbidity and mortality in hemodialysis patients. J Am Coll Cardiol. 2014 Feb 18;63(6):528-36. doi: 10.1016/j.jacc.2013.09.056. Epub 2013 Oct 30. |
| 33586138 | Derived | Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 21, 2020 | Sep 11, 2020 |
| ID | Term |
|---|---|
| D061205 | Vascular Calcification |
| ID | Term |
|---|---|
| D002114 | Calcinosis |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D013148 | Spironolactone |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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