The Impact of CRT on Renal Function

Sponsor

University of Rzeszow (Other)

Overall Status

Completed

CT.gov ID

NCT04516525

Collaborator

(none)

Enrollment

51.7

Actual Duration (Months)

Study Details

Study Description

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	Phase
Chronic Kidney Diseases Chronic Heart Failure	Device: cardiac resynchronisation therapy (CRT) implantation

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

74 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Assessment of the Impact of Resynchronization Therapy on Renal Function

Actual Study Start Date :

Apr 15, 2016

Actual Primary Completion Date :

Dec 15, 2018

Actual Study Completion Date :

Aug 6, 2020

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

No locations specified.

Sponsors and Collaborators

University of Rzeszow

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Gala-Błądzińska A, Romanek J, Mazur D, Stepek T, Braun M, Szafarz P, Chlebuś M, Przybylski A. Reduced Albuminuria and Potassemia Indicate Early Renal Repair Processes after Resynchronization Therapy in Cardiorenal Syndrome Type 2. Cardiol Res Pract. 2020 Mar 21;2020:2727108. doi: 10.1155/2020/2727108. eCollection 2020.

Responsible Party:

Agnieszka Gala-Bladzinska, Principal Investigator, University of Rzeszow

ClinicalTrials.gov Identifier:

NCT04516525

Other Study ID Numbers:

1/AGB

First Posted:

Aug 18, 2020

Last Update Posted:

Aug 18, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Agnieszka Gala-Bladzinska, Principal Investigator, University of Rzeszow

Chronic cardio-renal syndrome biomarkers

Additional relevant MeSH terms:

Kidney Diseases

Renal Insufficiency, Chronic

Study Results

No Results Posted as of Aug 18, 2020