NCT01024049

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

5.4 years

First QC Date

November 30, 2009

Last Update Submit

January 27, 2012

Conditions

Heart Failure

Keywords

heart failure blood left ventricular dysfunction

Study Arms (5)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toulouse, Midi-Pyrénées, 31432, France

RECRUITING

Related Publications (2)

  • 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.

    PMID: 40877033DERIVED

  • 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.

    PMID: 25786035DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma sample blood RNA sample

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Michel Galinier, MD-PHD

    Hospital of Toulouse, INSERM

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel Galinier, MD-PHD

CONTACT

(33)56 13 22 661galinier.m@chu-toulouse.fr

Philippe Rouet, PHD

CONTACT

(33)5 61 32 34 83philippe.rouet@inserm.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

July 1, 2007

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

FR(1)