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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-07

Study Completion Date

2016-11-10

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Calcification Vascular Calcification

Keywords

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Vascular calcification Coronary calcification Peritoneal Dialysis Spironolactone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Spironolactone group

Spironolactone oral tablet 25mg/day, for 12 months

Group Type EXPERIMENTAL

Spironolactone 25Mg Tablet

Intervention Type DRUG

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

Control group

No spironolactone use

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Spironolactone 25Mg Tablet

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Alex Sandro Rolland de Souza

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR