Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction (IBLOMAVED)
|ClinicalTrials.gov Identifier: NCT01024049|
Recruitment Status : Unknown
Verified January 2012 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was: Recruiting
First Posted : December 2, 2009
Last Update Posted : January 31, 2012
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Observational Model:||Case Control|
|Official Title:||Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction|
|Study Start Date :||July 2007|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
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).
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024049
|Contact: Michel Galinier, MD-PHD||(33)56 13 22 email@example.com|
|Contact: Philippe Rouet, PHD||(33)5 61 32 34 firstname.lastname@example.org|
|Hospital from Toulouse Rangueil, Pr Galinier department (Cardiology A)||Recruiting|
|Toulouse, Midi-Pyrénées, France, 31432|
|Contact: Michel Galinier, MD-PhD (33)561 32 2661 email@example.com|
|Contact: Philippe Rouet, PhD (33)562172951 firstname.lastname@example.org|
|Principal Investigator:||Michel Galinier, MD-PHD||Hospital of Toulouse, INSERM|