NCT02170961

Brief Summary

this study aim to investigate the:

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2013

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 23, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 11, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

June 19, 2014

Last Update Submit

August 10, 2020

Conditions

Acute Heart Failure

Keywords

Acute heart failureRAASMMP3MMP12Polymorphysm

Outcome Measures

Primary Outcomes (1)

  • mortality RAAS

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

    one year

Secondary Outcomes (2)

  • association between RAAS polymorphism and AHF

    at admission (an average of 1 day)

  • association between MMP polymorphism and AHF

    at admission (average of 1 day)

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Acute onset dyspnea patients

You may qualify if:

  • aged more than 18 year old.
  • acute non traumatic dyspnea .

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nouira Samir

Monastir, Emergency Department Monastir, Tunisia 5000, 5000, Tunisia

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

arterial blood samples collected in EDTA tubes and stored in - 20°C envirement for DNA extraction with salting out methods.

Study Officials

  • Nouira Samir, Professor

    University of Monastir

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 19, 2014

First Posted

June 23, 2014

Study Start

February 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

August 11, 2020

Record last verified: 2020-08

Locations

TU(1)