Condition category
Urological and Genital Diseases
Date applied
31/07/2018
Date assigned
22/08/2018
Last edited
21/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results

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

Trial website

www.incor.usp.br

Contact information

Type

Public

Primary contact

Dr Thiago Hueb

ORCID ID

Contact details

Av Dr Eneas Carvalho Aguiar 44
São Paulo
05403000
Brazil

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of chronic kidney disease in ischemic cardiomyopathy: Long-term follow-up - REVISION-DM2 Trial

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

Institutional Review Board, 25/05/2011, SDC 3585/11/003

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

Trial setting

Hospitals

Trial type

Other

Patient information sheet

No participant information sheet available

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

Phase

Drug names

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 trial start date

24/09/2010

Overall trial end date

20/11/2018

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

918

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

Trial participating centre

Instituto do Coracao (InCor), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de São Paulo, SP, BR
Av Dr Eneas Carvalho Aguiar 44
São Paulo
05403000
Brazil

Trial participating centre

Zerbini Foundation
Av Dr Eneas Carvalho Aguiar 44
São Paulo
05403000
Brazil

Sponsor information

Organisation

Zerbini Foundation

Sponsor details

Av. Dr . Eneas Carvalho Aguiar 44
São Paulo
05403000
Brazil

Sponsor type

Charity

Website

www.zerbini.org.br

Funders

Funder type

Not defined

Funder name

Zerbini Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We intend to submit for publication in BMC Cardiovascular Disorders in 2018

IPD sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

15/09/2018

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30896618 [added 29/03/2019]

Publication citations

Additional files

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'.