Acute Heart FailurePRA-MMPNCT02170961
Study of Polymorphisms of RAAS and MMPs in Acute Heart Failure
An observational study of Acute Heart Failure, run by University of Monastir at 1 site in Tunisia.
Trial summary
this study aim to investigate the: association of RAAS polymorphisms and AHF association of MMP 3 and 12 polymorphisms and AHF Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure
- How many people
- 300 participants
- Where
- 1 siteTunisia
- Study dates
- Feb 2013to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Acute onset dyspnea patients
Who may be able to join
- aged more than 18 year old.
- acute non traumatic dyspnea .
Who cannot join
- 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,
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
Nouira Samir
Monastir, Emergency Department Monastir, Tunisia 5000, 5000
About this study
Official title: 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
Read the 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.
- Conditions
- Acute Heart Failure
- Keywords
- Acute heart failure, RAAS, MMP3, MMP12, Polymorphysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
mortality RAAS
the association between RAAS genes polymorphisms and mortality at one year average
Measured: one year
Secondary outcomes (2)
association between RAAS polymorphism and AHF
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.
Measured: at admission (an average of 1 day)
association between MMP polymorphism and AHF
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.
Measured: at admission (average of 1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startFeb 2013
- Primary completionDec 2015
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Monastir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pr. Semir Nouira, University of Monastir
- Investigators
- Nouira Samir, Professor, Principal investigator, University of Monastir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170961
- Sponsor's protocol ID
- PRA-MMP
- Acronym
- PRA-MMP
- Status last verified
- Aug 2020
- First submitted
- 19 Jun 2014
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Polymorphisms of Renin Angiotensin Aldosteron Systemv(RAAS) and Matrice Metallo Protesase (MMPs) in Acute Heart Failure (AHF)
- ClinicalTrials.gov ID
- NCT02170961
- Acronym / sponsor ID
- PRA-MMP / PRA-MMP
- Conditions
- Acute Heart Failure
- Keywords
- Acute heart failure, RAAS, MMP3, MMP12, Polymorphysm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of MonastirUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study aim to investigate the:
- association of RAAS polymorphisms and AHF
- association of MMP 3 and 12 polymorphisms and AHF
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute onset dyspnea patients
Key inclusion criteria (2 listed)
- aged more than 18 year old.
- acute non traumatic dyspnea .
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mortality RAAS
Time frame: one year
the association between RAAS genes polymorphisms and mortality at one year average
2 secondary outcomes
association between RAAS polymorphism and AHF
Time frame: at admission (an average of 1 day)
association between MMP polymorphism and AHF
Time frame: at admission (average of 1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- official websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nouira Samir, Professor principal investigator
University of Monastir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by University of Monastir at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality RAAS (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020.