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The Impact of CRT on Renal Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04516525
Recruitment Status : Completed
First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
Agnieszka Gala-Bladzinska, University of Rzeszow

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Kidney Diseases Chronic Heart Failure Device: cardiac resynchronisation therapy (CRT) implantation

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 74 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Years
Official Title: Assessment of the Impact of Resynchronization Therapy on Renal Function
Actual Study Start Date : April 15, 2016
Actual Primary Completion Date : December 15, 2018
Actual Study Completion Date : August 6, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Groups and Cohorts
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Intervention Details:
  • Device: cardiac resynchronisation therapy (CRT) implantation
    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.

Outcome Measures
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Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
blood, urina

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Agnieszka Gala-Bladzinska, Principal Investigator, University of Rzeszow
ClinicalTrials.gov Identifier: NCT04516525    
Other Study ID Numbers: 1/AGB
First Posted: August 18, 2020    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The datasets used and/or analyzed in the current study are available from the corresponding author on reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Agnieszka Gala-Bladzinska, University of Rzeszow:
Chronic cardio-renal syndrome biomarkers
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency