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

NCT03314493 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2017-10-19

No results posted yet for this study

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.

Conditions

  • Coronary Artery Calcification
  • Vascular Calcification

Interventions

DRUG

Spironolactone 25Mg Tablet

Patients with coronary calcium score \> 30 were treated with spironolactone for 12 months

Sponsors & Collaborators

  • Federal University of São Paulo

    collaborator OTHER
  • Professor Fernando Figueira Integral Medicine Institute

    lead OTHER

Principal Investigators

  • Ana Paula S Gueiros, MD · Instituto de Medicina Integral Prof. Fernando Figueira

  • Alex SR Souza, PhD · Instituto de Medicina Integral Prof. Fernando Figueira

  • Aluizio B Carvalho, PhD · Universidade Federal de São Paulo

  • José E Gueiros, MD · Instituto de Medicina Integral Prof. Fernando Figueira

  • Leuridan T Cavalcante, PhD · Instituto de Medicina Integral Prof. Fernando Figueira

  • Dulce E Casarini, PhD · Universidade Federal de São Paulo

  • Marina M Cadena · Instituto de Medicina Integral Prof. Fernando Figueira

  • Karina T Nobrega, MD · Instituto de Medicina Integral Prof. Fernando Figueira

  • Eveline B Calado, MD · Instituto de Medicina Integral Prof. Fernando Figueira

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-07
Primary Completion
2016-11-10
Completion
2016-11-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03314493 on ClinicalTrials.gov