Identification Of Blood Markers For Asymptomatic Ventricular Dysfunction

NCT ID: NCT01024049

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-07-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Groups

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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).

No interventions assigned to this group

healthy controls

individuals over 18 years old free of disease and treatments.

No interventions assigned to this group

patients with cardiovascular risk

patients with cardiovascular risk (obesity, diabetes, dyslipidemia, arterial hypertension, age, gender, familial history)

No interventions assigned to this group

chronic heart failure patients

patient with chronic heart failure

No interventions assigned to this group

acute heart failure patients

acute heart failure patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Galinier, MD-PHD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Toulouse, INSERM

Locations

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Hospital from Toulouse Rangueil, Pr Galinier department (Cardiology A)

Toulouse, Midi-Pyrénées, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Michel Galinier, MD-PHD

Role: CONTACT

(33)56 13 22 661

Philippe Rouet, PHD

Role: CONTACT

(33)5 61 32 34 83

Facility Contacts

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Michel Galinier, MD-PhD

Role: primary

(33)561 32 2661

Philippe Rouet, PhD

Role: backup

(33)562172951

References

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Rouet K, Rouet P, Koukoui F, Galinier M. Diagnostic accuracy and rapid testing of a novel acute heart failure biomarker: A laboratory evaluation and comparison with natriuretic peptides. Ann Clin Biochem. 2025 Aug 28:45632251378035. doi: 10.1177/00045632251378035. Online ahead of print.

Reference Type DERIVED
PMID: 40877033 (View on PubMed)

Koukoui F, Desmoulin F, Galinier M, Barutaut M, Caubere 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.

Reference Type DERIVED
PMID: 25786035 (View on PubMed)

Other Identifiers

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C06-15

Identifier Type: -

Identifier Source: org_study_id

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