The Impact of CRT on Renal Function

NCT04516525 | Completed DMC FDA Device

• 1 other identifier: 1/AGB
• Study Type: observational
• Target: 74
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Diseases; Chronic Heart Failure

Keywords

Chronic cardio-renal syndrome biomarkers

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Rzeszow: lead

Related 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.

  PMID: 32274209 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood, urina

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 18, 2020
• Study Start: April 15, 2016
• Primary Completion: December 15, 2018
• Study Completion: August 6, 2020
• Last Updated: August 18, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share