Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction (IBLOMAVED)

• ClinicalTrials.gov Identifier: NCT01024049
• Recruitment Status: Unknown
• First Posted: December 2, 2009
• Last Update Posted: January 31, 2012
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
• Information provided by (Responsible Party): Institut National de la Santé Et de la Recherche Médicale, France

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
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified 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

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

• 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.

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, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

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