Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction (IBLOMAVED)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier:
NCT01024049
First received: November 30, 2009
Last updated: January 27, 2012
Last verified: January 2012

November 30, 2009
January 27, 2012
July 2007
December 2012   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01024049 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction
Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction

The diagnosis of asymptomatic left ventricular dysfunction is difficult in general practice since it requires transthoracic cardiac echocardiography that is generally performed in specialized services. Although blood BNP levels monitoring can be of some help in heart failure diagnosis is is mostly a late biomarker that is secreted upon heart stretch and has many limitations. Therefore the aim of this study is to identify new specific blood biomarkers that would help for asymptomatic left ventricular dysfunction diagnosis in large populations with cardiovascular risk.

Recognition of asymptomatic left ventricular dysfunction (ALVD) and early stages of heart failure (HF) are a diagnostic challenge for physicians. Patient history and physical examination may fail to provide a definitive diagnosis; additional testing are required to aid in diagnosis. More than 20 million people worldwide are estimated to have HF. Despite recent therapeutic advances, morbidity and mortality after the onset of heart failure remain high (35 % at 5 years after diagnosis). In addition, the annual cost of heart failure is estimated to be greater than that of myocardial infarction and all cancers combined. Consequently, prevention of heart failure through identification and management of risk factors and preclinical phases of the disease is a priority. Clearly identification of asymptomatic patients is difficult but would prevent further development of HF by initiation of early adapted medical and non medical treatment.

We propose to search for markers of ALVD, in patients that have cardiovascular risk factors. These new biomarkers should be earlier, more specific and more accurate than the one that we already have such as B-type natriuretic peptide (BNP), which is the most recently, established. BNP has been clearly associated with HF but is a relatively late stage marker for HF and is not specific for HF. In addition BNP has been shown to be a poor marker in obese or diabetic patients. Therefore the need of early specific biomarkers for LVD before HF is irreversibly initiated is strong.

We propose to compare blood samples from 5 groups of patients carefully defined: 1) without cardiovascular risk factors ; 2) With cardiovascular risk factors and without ALVD; 3) With cardiovascular risk factors and with ALVD. 4) chronic heart failure patients ; 5) Acute heart failure patients. Groups will be matched for risk factors and treatments.

Three distinct approaches will be performed: - A transcriptomics one that will monitor white blood cell transcriptome ; a proteomic one that will use high throughput SELDI-TOF profiling and a metabolic profiling one using Nuclear Magnetic Resonance.

Observational
Observational Model: Case Control
Not Provided
Retention:   Samples Without DNA
Description:

plasma sample blood RNA sample

Non-Probability Sample
  1. Healthy individuals
  2. Patients with cardiovascular risk
  3. Patients with cardiovascular risk and asymptomatic left ventricular dysfunction
  4. Chronic heart failure patients
  5. Acute heart failure patients
Heart Failure
Not Provided
  • Asymptomatic LVD
    patients over 18 years old with patients with cardiovascular risk (obesity, diabetes, dyslipidemia, arterial hypertension, age, gender, familial history) and asymptomatic left ventricular dysfunction (LVD).
  • healthy controls
    individuals over 18 years old free of disease and treatments.
  • patients with cardiovascular risk
    patients with cardiovascular risk (obesity, diabetes, dyslipidemia, arterial hypertension, age, gender, familial history)
  • chronic heart failure patients
    patient with chronic heart failure
  • acute heart failure patients
    acute heart failure patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria (5 groups defined):

Patients with Obesity or diabetes or arterial hypertension with or without : acute or chronic heart failure, left ventricular hypertrophy, left ventricular dysfunction symptomatic or not.

Healthy control patients

Exclusion Criteria:

cancer and/or other other severe chronical or infectious pathologies. Patient is unable to sign or understand the consent form Patients is on any dialysis

Both
18 Years to 80 Years
Yes
Contact: Michel Galinier, MD-PHD (33)56 13 22 661 galinier.m@chu-toulouse.fr
Contact: Philippe Rouet, PHD (33)5 61 32 34 83 philippe.rouet@inserm.fr
France
 
NCT01024049
C06-15
No
Institut National de la Santé Et de la Recherche Médicale, France
Institut National de la Santé Et de la Recherche Médicale, France
Not Provided
Principal Investigator: Michel Galinier, MD-PHD Hospital of Toulouse, INSERM
Institut National de la Santé Et de la Recherche Médicale, France
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP