Chronic Kidney DiseasesNCT04516525
The Impact of CRT on Renal Function
An observational study of Chronic Kidney Diseases and Chronic Heart Failure, run by University of Rzeszow.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Chronic Heart Failure
- What is being tested?
- cardiac resynchronisation therapy (CRT) implantation
- Type of treatment
- Medical device
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2016to 6 Aug 2020
- How long will I take part?
- 4 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- no written consent to participate in the study
- no indications for CR implantation
- current infection
- children
- pregnant women
About this study
Official title: Assessment of the Impact of Resynchronization Therapy 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.
- Conditions
- Chronic Kidney Diseases, Chronic Heart Failure
- Being tested
- cardiac resynchronisation therapy (CRT) implantation
- Keywords
- Chronic cardio-renal syndrome biomarkers
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac resynchronisation therapy (CRT) implantationDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year for each patient in the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start15 Apr 2016
- Primary completion15 Dec 2018
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 74 participants (actual)
- Target duration
- 4 Years
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Gala-Bladzinska, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04516525
- Sponsor's protocol ID
- 1/AGB
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 18 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The datasets used and/or analyzed in the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 32274209
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Impact of Resynchronization Therapy on Renal Function
- ClinicalTrials.gov ID
- NCT04516525
- Acronym / sponsor ID
- 1/AGB
- Conditions
- Chronic Kidney Diseases, Chronic Heart Failure
- Keywords
- Chronic cardio-renal syndrome biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 15 Apr 2016 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 18 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- no written consent to participate in the study
- no indications for CR implantation
- current infection
- children
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cardiac resynchronisation therapy (CRT) implantationIn 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. | Device | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
- Background: PubMed 32274209Gala-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.
- Individual participant dataSharing planned: No. The datasets used and/or analyzed in the current study are available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Chronic Heart Failure, run by University of Rzeszow.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04516525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.