Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction (IBLOMAVED)

Tracking Information
First Submitted Date	November 30, 2009
First Posted Date	December 2, 2009
Last Update Posted Date	January 31, 2012
Study Start Date	July 2007
Estimated Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT01024049 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction
Official Title	Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction
Brief Summary	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.
Detailed Description	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
Study Design	Observational Model: Case Control
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples Without DNA; Description: plasma sample blood RNA sample
Sampling Method	Non-Probability Sample
Study Population	Healthy individuals; Patients with cardiovascular risk; Patients with cardiovascular risk and asymptomatic left ventricular dysfunction; Chronic heart failure patients; Acute heart failure patients
Condition	Heart Failure
Intervention	Not Provided
Study Groups/Cohorts	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
Publications *	Koukoui F, Desmoulin F, Galinier M, Barutaut M, Caubère C, Evaristi MF, Murat G, De Boer R, Berry M, Smih F, Rouet P. The prognostic value of plasma galectin-3 in chronic heart failure patients is maintained when treated with mineralocorticoid receptor antagonists. PLoS One. 2015 Mar 18;10(3):e0119160. doi: 10.1371/journal.pone.0119160. eCollection 2015.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Unknown status
Estimated Enrollment; (submitted: January 27, 2012)	1000
Original Estimated Enrollment; (submitted: December 1, 2009)	700
Estimated Study Completion Date	December 2012
Estimated Primary Completion Date	December 2012 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	Yes
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	France
Removed Location Countries
Administrative Information
NCT Number	NCT01024049
Other Study ID Numbers	C06-15
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Institut National de la Santé Et de la Recherche Médicale, France
Study Sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Collaborators	Not Provided
Investigators	Principal Investigator: Michel Galinier, MD-PHD Hospital of Toulouse, INSERM
PRS Account	Institut National de la Santé Et de la Recherche Médicale, France
Verification Date	January 2012