Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction (IBLOMAVED)
Recruitment status was Recruiting
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.
|Study Design:||Observational Model: Case Control|
|Official Title:||Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction|
plasma sample blood RNA sample
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024049
|Contact: Michel Galinier, MD-PHD||(33)56 13 22 firstname.lastname@example.org|
|Contact: Philippe Rouet, PHD||(33)5 61 32 34 email@example.com|
|Hospital from Toulouse Rangueil, Pr Galinier department (Cardiology A)||Recruiting|
|Toulouse, Midi-Pyrénées, France, 31432|
|Contact: Michel Galinier, MD-PhD (33)561 32 2661 firstname.lastname@example.org|
|Contact: Philippe Rouet, PhD (33)562172951 email@example.com|
|Principal Investigator:||Michel Galinier, MD-PHD||Hospital of Toulouse, INSERM|