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OpenTrials
Completed

NCT Number: NCT04516525

The Impact of CRT on Renal Function

The study is observational, prospective, including patients undergoing CRT-D / CRT-P implantation in the department of cardiology. In the current project, the researchers assumed that the improvement in cardiac function obtained in patients qualified according to the ESC / PTK guidelines for resynchronization therapy may improve renal function in a prospective 12-month follow-up. In addition, it is planned to take into account the possibility of temporary deterioration of kidney function, which may occur immediately after implantation of the resynchronization device due to the nephrotoxic effect of the contrast agent.

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Key information

Who can participate

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

Inclusion criteria

Adult patients with heart failure who had met the criteria for CRT implantation according to European Society of Cardiology guidelines for the treatment of heart failure

Exclusion criteria

  • no written consent to participate in the study
  • no indications for CR implantation
  • current infection
  • children
  • pregnant women

Treatment and study plan

cardiac resynchronisation therapy (CRT) implantation

Device

In a group of 100 patients with chronic cardio-renal syndrome, the blood and urine biomarkers are tested before CRT implantation and after 48 hours, 3 months and 1 year of follow-up.

Primary outcomes

  1. Evaluation of changes renal function: 48 hours, one month and one year after cardiac resynchronization therapy device implantation procedure.

    Time frame: 1 year for each patient in the study

    Assessment of the number of patients with with chronic type 2 cardio-renal syndrome with improvement or deterioration renal function assessed by blood and urine biomarkers within the first 48 hours, one month and one year after CRT implantation.

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Registry information

Official study title

Assessment of the Impact of Resynchronization Therapy on Renal Function

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Aug 18, 2020
Registry last updated
Aug 18, 2020

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.

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