The Impact of CRT on Renal Function

Chronic Kidney Diseases Clinical Trial

Official title:

Assessment of the Impact of Resynchronization Therapy on Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04516525
• Other study ID #: 1/AGB
• Status: Completed
• Start date: April 15, 2016
• Est. completion date: August 6, 2020

Study information

• Verified date: August 2020
• Source: University of Rzeszow
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 6, 2020
• Est. primary completion date: December 15, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Rzeszow

References & Publications (1)

Gala-Bladzinska A, Romanek J, Mazur D, Stepek T, Braun M, Szafarz P, Chlebus 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of changes renal function: 48 hours, one month and one year after cardiac resynchronization therapy device implantation procedure.	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.	1 year for each patient in the study