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

Professor Fernando Figueira Integral Medicine Institute

Status and phase: Completed; Phase 3

Conditions: Vascular Calcification; Coronary Artery Calcification

Treatments: Drug: Spironolactone 25Mg Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT03314493

U1111-1203-1767

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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33 participants in 2 patient groups

Spironolactone group

Experimental group

Description:

Spironolactone oral tablet 25mg/day, for 12 months

Treatment:

Drug: Spironolactone 25Mg Tablet

Control group

No Intervention group

Description:

No spironolactone use