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

October 15, 2017 updated by: Alex Sandro Rolland de Souza, Professor Fernando Figueira Integral Medicine Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Pernambuco
      • Recife, Pernambuco, Brazil, 50070-550
        • Instituto de Medicina Integral Prof. Fernando Figueira

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Professor Fernando Figueira Integral Medicine Institute

Collaborators

Federal University of São Paulo

Investigators

  • Principal Investigator: 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
  • Study Director: Aluizio B Carvalho, PhD, Universidade Federal de Sao Paulo
  • Study Chair: 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 Sao 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2014

Primary Completion (Actual)

November 10, 2016

Study Completion (Actual)

November 10, 2016

Study Registration Dates

First Submitted

October 4, 2017

First Submitted That Met QC Criteria

October 15, 2017

First Posted (Actual)

October 19, 2017

Study Record Updates

Last Update Posted (Actual)

October 19, 2017

Last Update Submitted That Met QC Criteria

October 15, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1203-1767

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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