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

August 10, 2020 updated by: Pr. Semir Nouira, University of Monastir

Study of Polymorphisms of Renin Angiotensin Aldosteron Systemv(RAAS) and Matrice Metallo Protesase (MMPs) in Acute Heart Failure (AHF)

this study aim to investigate the:

  • association of RAAS polymorphisms and AHF
  • association of MMP 3 and 12 polymorphisms and AHF

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Tunisia
    • Emergency Department Monastir, Tunisia 5000
      • Monastir, Emergency Department Monastir, Tunisia 5000, Tunisia, 5000
        • Nouira Samir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Acute onset dyspnea patients

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mortality RAAS
Time Frame: one year
the association between RAAS genes polymorphisms and mortality at one year average
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
association between RAAS polymorphism and AHF
Time Frame: 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.
at admission (an average of 1 day)
association between MMP polymorphism and AHF
Time Frame: 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.
at admission (average of 1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Monastir

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

June 19, 2014

First Submitted That Met QC Criteria

June 19, 2014

First Posted (Estimate)

June 23, 2014

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 10, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRA-MMP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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