Acute Heart FailureEMEPICNCT00568165
EMEPIC : Value of a Mobile Team of Cardiologist Using Echocardiography for Managing Patients With Acute Heart Failure
A study testing Mobile team in people with Acute Heart Failure and Congestive Edema, run by University Paris 7 - Denis Diderot at 1 site in France.
Trial summary
The aim of the study is to compare clinical management of patients with acute decompensation of heart failure, hospitalized in non cardiological ward, with the use of a mobile team including a cardiologist with portable echocardiography and standard care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Congestive Edema, Cardiac Disease
- What is being tested?
- Mobile team
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Jul 2010
- Phase
- Interventional
- 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
Who may be able to join
- Hospitalized for suspected heart failure
- > or = 18 years
Who cannot join
- Refuses to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Value of a Mobile Team of Cardiologist Using Echocardiography for Managing Patients With Acute Heart Failure
The aim of the study is to compare clinical management of patients with acute decompensation of heart failure, hospitalized in non cardiological ward, with the use of a mobile team including a cardiologist with portable echocardiography and standard care. The hypothesis is that a mobile team will lead to shorter hospitalization.
Read the detailed description
Randomized, controlled, monocentric study comparing Standard care with the care provided by a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward on the duration of hospitalization, re-hospitalization rate à 30 days, emergency visit within 30 days, treatment at discharge, mortality within hospital stay and at 30 days.
- Conditions
- Acute Heart Failure, Congestive Edema, Cardiac Disease
- Being tested
- Mobile team, Standard care
- Keywords
- Heart failure, congestive, Echocardiography, Patient care team
- Medical subject headings
- Heart Diseases, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile teamProcedure or surgery
a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward
Standard careProcedure or surgery
Standard care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Mobile Team Receives: Procedure: Mobile team |
| 2 | Active comparator | Standard care Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization.
Measured: 30 days
Secondary outcomes (1)
Re-hospitalization rate à 30 days Emergency visit within 30 days Treatment at discharge Mortality within hospital stay Mortality at 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study startFeb 2008
- Primary completionJun 2010
- Study completionJul 2010
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Paris 7 - Denis Diderot
- Sponsor type
- University, hospital or other
- Investigators
- Guillaume JONDEAU, MD, PhD, Principal investigator, UNIVERSITY PARIS 7
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568165
- Sponsor's protocol ID
- Code IDRCD : 2007- A00640 - 53
- Other IDs
- N°CPP : 0711602, N°CCTIRS : 07331
- Acronym
- EMEPIC
- Status last verified
- Aug 2010
- First submitted
- 4 Dec 2007
- Last updated
- 26 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of a Mobile Team of Cardiologist Using Echocardiography for Managing Patients With Acute Heart Failure
- ClinicalTrials.gov ID
- NCT00568165
- Acronym / sponsor ID
- EMEPIC / Code IDRCD : 2007- A00640 - 53
- Conditions
- Acute Heart Failure, Congestive Edema, Cardiac Disease
- Keywords
- Heart failure, congestive, Echocardiography, Patient care team
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- University Paris 7 - Denis DiderotUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Dec 2007 (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.
The aim of the study is to compare clinical management of patients with acute decompensation of heart failure, hospitalized in non cardiological ward, with the use of a mobile team including a cardiologist with portable echocardiography and standard care. The hypothesis is that a mobile team will lead to shorter hospitalization.
Detailed description
Randomized, controlled, monocentric study comparing Standard care with the care provided by a mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward on the duration of hospitalization, re-hospitalization rate à 30 days, emergency visit within 30 days, treatment at discharge, mortality within hospital stay and at 30 days.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Mobile teamMobile Team |
| 2 | Active comparator | Procedure: Standard careStandard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hospitalized for suspected heart failure
- > or = 18 years
Key exclusion criteria (1 listed)
- Refuses to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile teama mobile team including a cardiologist with mobile echocardiography, systematic follow up à 3 days, a dietician advice in patients hospitalized for acute heart failure in a non cardiology ward | Procedure or surgery | 1 |
| Standard careStandard care | Procedure or surgery | 2 |
Primary outcome
Duration of hospitalization.
Time frame: 30 days
1 secondary outcome
Re-hospitalization rate à 30 days Emergency visit within 30 days Treatment at discharge Mortality within hospital stay Mortality at 30 days
Time frame: 30 days
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 26 Oct 2010.
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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.
Guillaume JONDEAU, MD, PhD principal investigator
UNIVERSITY PARIS 7
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile team in people with Acute Heart Failure and Congestive Edema, run by University Paris 7 - Denis Diderot at 1 site in France.
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 1 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 26 Oct 2010. 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 France. 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?
Duration of hospitalization. (time frame: 30 days). 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 26 Oct 2010.