Skip to main content
OpenTrials
Completed

NCT Number: NCT03314493

Prevention of the Progression of Coronary Calcification With Use of Spironolactone 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Calcification Calcinosis Calcium Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Instituto de Medicina Integral Prof. Fernando Figueira

Recife, Pernambuco, 50070-550, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spironolactone 25Mg Tablet

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Professor Fernando Figueira Integral Medicine Institute

Other

Collaborators

  • Federal University of São Paulo

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 19, 2017
Registry last updated
Oct 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.