Heart FailurePREDICANCT02835963
Acute Heart Failure Study in Patients Admitted to Emergency Department for Dyspnea
An observational study of Heart Failure, run by University Hospital, Toulouse at 3 sites in France.
Trial summary
No studies have analyzed the predictive value of different anamnestic and clinical signs for the diagnosis of acute heart failure (AHF) in patients admitted to emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Data collection
- How many people
- 342 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2016to 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: The population from which the cohort will be selected is patients admitted to hospital center emergency department of Toulouse, Bordeaux and Pau.
Who may be able to join
- patients ≥ 18 years
- Admitted to emergency department for acute dyspnea
Who cannot join
- Traumatic dyspnea
- shock / Systolic blood pressure <90 mmHg
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospital
Bordeaux, 33000
Hospital
Pau, 64000
University Hospital Toulouse
Toulouse, 31000
About this study
Official title: Predictive Criteria of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department for Dyspnea.
No studies have analyzed the predictive value of different anamnestic and clinical signs for the diagnosis of acute heart failure (AHF) in patients admitted to emergency department. That's why the expert group of the AHF of South West of France mobilizes to conduct this study to evaluate the diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF to emergencies.
Read the detailed description
There is no recommendation of the French Society of Emergency Medicine (SFMU) on the management of the acute heart failure in the emergency department.
The present study hypothesizes that identifying anamnestic and clinical criteria of AHF in patients admitted to emergency department for acute dyspnea would optimize the management of these patients upon arrival to the emergency department and to implement rapidly the appropriate therapeutic strategies.
All patients admitted for dyspnea will be enrolled by the emergency physicians (after verification of inclusion and exclusion criteria) in the 3 participating centers.
Then, all files will be analyzed retrospectively from information collected by a committee of experts cardiologists and emergency physicians of each center.
The primary objective is the evaluation of diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF in emergency department for the construction of a clinical prediction score of acute heart failure. The secondary objective is the description of the diagnostic and therapeutic management of patients admitted to the emergency for acute dyspnea.
- Conditions
- Heart Failure
- Being tested
- Data collection
- Keywords
- acute heart failure, dyspnea, predictive value
- Medical subject headings
- Heart Failure, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Usual data collection
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnosis of AHF after expertise
The final diagnosis of AHF after expertise of patients records by a committee of experts cardiologists and emergency physicians.
Measured: 12 months
Secondary outcomes (1)
Diagnostic and therapeutic management of patients admitted to the emergency for acute dyspnea
The secondary objective is the description of the diagnostic and therapeutic management of patients admitted to the emergency for acute dyspnea
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHARPENTIER Sandrine, MD PhD, Principal investigator, University Hospital, ToulouseRONCALLI Jérome, MD PhD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835963
- Sponsor's protocol ID
- RC/31/15/7672
- Acronym
- PREDICA
- Status last verified
- Jan 2022
- First submitted
- 7 Jul 2016
- Last updated
- 28 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Roncalli J, Picard F, Delarche N, Faure I, Pradeau C, Thicoipe M, Galinier M, Charpentier S. Predictive criteria for acute heart failure in emergency department patients with acute dyspnoea: the PREDICA study. Eur J Emerg Med. 2019 Dec;26(6):400-404. doi: 10.1097/MEJ.0000000000000622.
PubMed 31453847
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Criteria of Acute Heart Failure (AHF) in Patients Admitted to Emergency Department for Dyspnea.
- ClinicalTrials.gov ID
- NCT02835963
- Acronym / sponsor ID
- PREDICA / RC/31/15/7672
- Conditions
- Heart Failure
- Keywords
- acute heart failure, dyspnea, predictive value
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 18 Jul 2016 (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.
No studies have analyzed the predictive value of different anamnestic and clinical signs for the diagnosis of acute heart failure (AHF) in patients admitted to emergency department. That's why the expert group of the AHF of South West of France mobilizes to conduct this study to evaluate the diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF to emergencies.
Detailed description
There is no recommendation of the French Society of Emergency Medicine (SFMU) on the management of the acute heart failure in the emergency department.
The present study hypothesizes that identifying anamnestic and clinical criteria of AHF in patients admitted to emergency department for acute dyspnea would optimize the management of these patients upon arrival to the emergency department and to implement rapidly the appropriate therapeutic strategies.
All patients admitted for dyspnea will be enrolled by the emergency physicians (after verification of inclusion and exclusion criteria) in the 3 participating centers.
Then, all files will be analyzed retrospectively from information collected by a committee of experts cardiologists and emergency physicians of each center.
The primary objective is the evaluation of diagnostic predictive value of different anamnestic and clinical signs for the diagnosis of AHF in emergency department for the construction of a clinical prediction score of acute heart failure. The secondary objective is the description of the diagnostic and therapeutic management of patients admitted to the emergency for acute dyspnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population from which the cohort will be selected is patients admitted to hospital center emergency department of Toulouse, Bordeaux and Pau.
Key inclusion criteria (2 listed)
- patients ≥ 18 years
- Admitted to emergency department for acute dyspnea
Key exclusion criteria (2 listed)
- Traumatic dyspnea
- shock / Systolic blood pressure <90 mmHg
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 |
|---|---|---|
| Data collectionUsual data collection | Other | – |
Primary outcome
diagnosis of AHF after expertise
Time frame: 12 months
The final diagnosis of AHF after expertise of patients records by a committee of experts cardiologists and emergency physicians.
1 secondary outcome
Diagnostic and therapeutic management of patients admitted to the emergency for acute dyspnea
Time frame: Baseline
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 28 Jan 2022.
- Results publication: PubMed 31453847Roncalli J, Picard F, Delarche N, Faure I, Pradeau C, Thicoipe M, Galinier M, Charpentier S. Predictive criteria for acute heart failure in emergency department patients with acute dyspnoea: the PREDICA study. Eur J Emerg Med. 2019 Dec;26(6):400-404. doi: 10.1097/MEJ.0000000000000622.
- Individual participant dataSharing planned: Undecided
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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.
CHARPENTIER Sandrine, MD PhD principal investigator
University Hospital, Toulouse
RONCALLI Jérome, MD PhD principal investigator
University Hospital, Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by University Hospital, Toulouse at 3 sites 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 2 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 28 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
diagnosis of AHF after expertise (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02835963, which also lists 1 linked publication.
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 28 Jan 2022.