The effects of chronic kidney disease in ischemic cardiomyopathy
| ISRCTN | ISRCTN17786790 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17786790 |
| Secondary identifying numbers | N/A |
- Submission date
- 31/07/2018
- Registration date
- 22/08/2018
- Last edited
- 21/07/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English Summary
Background and study aims
Chronic kidney disease (CKD) affects patients of different ages and ethnicities worldwide, and is a risk factor for cardiovascular diseases. Creatinine is a protein found in the blood and is used to measure the efficiency of the kidneys. Mild-to-moderate elevations in creatinine in the serum of the blood are associated with increase rates of death, especially from cardiovascular diseases. However, whether CKD independently increases the risk of cardiovascular disease has not been established, and the relationship between kidney function and ischemic cardiomyopathy (weakened heart muscles, a type of cardiovascular disease) is poorly studied.
The aim of this study was to look at the relationship between CKD and ischemic cardiomyopathy in patients with coronary artery disease (CAD).
Who can participate?
Adults with CAD who have previously been treated with angioplasty, myocardial revascularization and clinical treatment according to cardiac and renal function
What does the study involve?
There is no direct involvement from participants in this study, as the study observes the outpatient follow-up period.
What are the possible benefits and risks of participating?
There are no known benefits or risks to participants taking part in this study as it does not involve direct participation.
Where is the study run from?
Heart Institute of the University of São Paulo, Brazil
When is the study starting and how long is it expected to run for?
September 2010 to November 2018
Who is funding the study?
Zerbini Foundation (Brazil)
Who is the main contact?
Dr Thiago Hueb
thiagohueb51@gmail.com
Contact information
Public
Av Dr Eneas Carvalho Aguiar 44
São Paulo
05403000
Brazil
Study information
| Study design | Observational prospective single-center non-randomized outpatients long term follow-up case-control study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | The effect of chronic kidney disease in ischemic cardiomyopathy: Long-term follow-up - REVISION-DM2 Trial |
| Study acronym | REVISION DM2 |
| Study hypothesis | Several studies suggest that mild-to-moderate elevations in serum creatinine levels are associated with increased rates of death from any cause and from cardiovascular causes, but whether chronic kidney disease independently increases the risk of any type of cardiovascular disease has not been established. In addition, the relationship between renal function and ischemic cardiomyopathy remains poorly studied. We aim to look at the effects of chronic kidney disease in ischemic cardiomyopathy. |
| Ethics approval(s) | Institutional Review Board, 25/05/2011, SDC 3585/11/003 |
| Condition | Chronic kidney disease in ischemic cardiomyopathy |
| Intervention | This study will include 2160 patients with coronary artery disease (CAD) previously treated by surgery, percutaneous revascularization, or medical treatment in an outpatient follow-up for 5 years. The ventricular function and glomerular filtration will be determined during the inclusion of the patient in the study. The calculation of the glomerular filtration will be done by the Cockcroft-Gault method and the ventricular function through the echocardiogram by the Simpson method. The major adverse cardiovascular events analyzed during follow-up will include death from any cause, including nonfatal myocardial infarction, unplanned revascularization, and stroke. |
| Intervention type | Mixed |
| Primary outcome measure | The following are assessed throughout the study, from the date of inclusion to the end of the study: 1. Mortality from any cause 2. Non-fatal myocardial infarction, defined as the following: 2.1. Elevation of specific cardiac enzymes within 14 days of a revascularization procedure 2.2. Presence of new Q waves in at least 2 or more contiguous leads 2.3. CK-MB (creatine kinase-muscle/brain)( or troponin US elevation, 10 times above normal level 3. Unplanned cardiac surgery - the need for unplanned revascularization, after symptoms of angina after coronary surgery with or without cardiopulmonary bypass 4. Stroke, defined as one of the following: 4.1. Patients with a focal neurological deficit of central origin, lasting more than 72 hours 4.2. Focal neurological deficit of central origin, lasting more than 24 hours, with imaging evidence of cerebral infarction or intracerebral haemorrhage 4.3. Non-focal encephalopathy, with imaging evidence of cerebral infarction 4.4. Haemorrhage adequate to account for the clinical state 5. Hospital admissions for cardiac causes, including the following: 5.1. Anginal symptoms 5.2. Heart failure 5.3. Generalized edema 5.4. Cardiac arrhythmia 6. Hospital admissions for renal causes, including the following: 6.1. Loss of urinary volume 6.2. Increase of plasmatic potassium without specific cause 6.3. Generalised edema |
| Secondary outcome measures | Quality of life, assessed every 6 months for 5 years using a questionnaire evaluating topics including the following: 1. Pain 2. Vitality 3. Emotional aspects 4. Physical aspects |
| Overall study start date | 24/09/2010 |
| Overall study end date | 20/11/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 918 |
| Participant inclusion criteria | 1. Stable angina 2. Multi-vessel coronary artery disease 3. Had an evaluation of left ventricular function 4. Aged 18 years or older |
| Participant exclusion criteria | 1. In dialysis programs 2. Pacemaker 3. Defibrillators 4. Reduced life expectancy 5. Degenerative diseases |
| Recruitment start date | 25/05/2011 |
| Recruitment end date | 11/07/2016 |
Locations
Countries of recruitment
- Brazil
Study participating centres
São Paulo
05403000
Brazil
São Paulo
05403000
Brazil
Sponsor information
Charity
Av. Dr . Eneas Carvalho Aguiar 44
São Paulo
05403000
Brazil
| Website | www.zerbini.org.br |
|---|---|
"ROR" |
https://ror.org/003c2h870 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 15/09/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | We intend to submit for publication in BMC Cardiovascular Disorders in 2018 |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2019 | 29/03/2019 | Yes | No |
Editorial Notes
21/07/2020: The public contact's details have been changed and the plain English summary updated accordingly.
29/03/2019: Publication reference added.
22/02/2019: The intervention type has been changed from 'drug' to 'mixed'.
