PRA-MMP: Study of Polymorphisms of RAAS and MMPs in Acute Heart Failure

Sponsor
University of Monastir (Other)
Overall Status
Completed
CT.gov ID
NCT02170961
Collaborator
(none)
300
1
46
6.5

Study Details

Study Description

Brief Summary

this study aim to investigate the:

  • association of RAAS polymorphisms and AHF

  • association of MMP 3 and 12 polymorphisms and AHF

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Heart failure can be defined as a complex clinical syndrome that results from any structural or functional disorder of the heart, with impairment of ability to fill the ventricles or eject blood. The main event of the IC is dyspnea and fatigue, which limit exercise tolerance and induces water retention.

    The renin angiotensin aldosterone system governs the salt and water homeostasis in the body. Renin is a proteolytic enzyme secreted by the juxtaglomerular apparatus of the kidney (area near the glomeruli). Renin has no direct action on the organism, but that is part of the renin-angiotensin system or the renin-angiotensin-aldosterone system is known.

    To date, few published studies have examined the association between the polymorphism AGT M235T * and cardiac dysfunction; and available results are contradictory. What is not known yet is the ratio of this polymorphism with the prognosis of heart failure.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Study of Polymorphisms of Renin Angiotensin Aldosteron Systemv(RAAS) and Matrice Metallo Protesase (MMPs) in Acute Heart Failure (AHF)
    Actual Study Start Date :
    Feb 1, 2013
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Dec 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    acute heart failure (AHF)

    patients consulting the emergency department for dyspnea. the diagnosis of AHF was based on clinical, biological (BNP) and echocardiographic data.

    Non acute heart failure (NAHF)

    patients consulting the emergency department for dyspnea. the diagnosis of AHF was based on clinical, biological (BNP) and echocardiographic data.

    Outcome Measures

    Primary Outcome Measures

    1. mortality RAAS [one year]

      the association between RAAS genes polymorphisms and mortality at one year average

    Secondary Outcome Measures

    1. association between RAAS polymorphism and AHF [at admission (an average of 1 day)]

      the association between the diagnosis of AHF (based on clinical, BNP, and echocardiographic finds) and the RAAS genes polymorphism is studied at patient admission for acute dyspnea.

    2. association between MMP polymorphism and AHF [at admission (average of 1 day)]

      the association between the diagnosis of AHF (based on clinical, BNP, and echocardiographic finds) and the MMP genes polymorphism is studied at patient admission for acute dyspnea.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • aged more than 18 year old.

    • acute non traumatic dyspnea .

    Exclusion Criteria:
    • ECG diagnostic for acute myocardial infarction or ischemic chest pain within the prior 24 hours

    • a history of a heart transplant, pericardial effusion, chest wall deformity suspected of causing dyspnea

    • coma, shock,MV,vasopressor drugs

    • arrhythmia serious and sustained,

    • pace maker

    • severe mitral valve disease,

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nouira Samir Monastir Emergency Department Monastir, Tunisia 5000 Tunisia 5000

    Sponsors and Collaborators

    • University of Monastir

    Investigators

    • Principal Investigator: Nouira Samir, Professor, University of Monastir

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pr. Semir Nouira, Professor, University of Monastir
    ClinicalTrials.gov Identifier:
    NCT02170961
    Other Study ID Numbers:
    • PRA-MMP
    First Posted:
    Jun 23, 2014
    Last Update Posted:
    Aug 11, 2020
    Last Verified:
    Aug 1, 2020
    Keywords provided by Pr. Semir Nouira, Professor, University of Monastir
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 11, 2020