Acute Heart FailureNCT03903198
Care Pathways of Acute Heart Failure Patients: Impact on In-hospital Mortality.
An observational study of Acute Heart Failure, run by frederic ADNET.
Trial summary
The investigators conducted a prospective observational study to describe the different pre-hospital and in-hospital pathways of patients with acute heart failure (AHF) and their association with in-hospital mortality. 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
- 3,677 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Oct 2018
- 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: Patients hospitalized in 26 french hospitals for Acute Heart Failure
Who may be able to join
- All patients presenting to hospital with Acute Heart Failure according to the physician in care
Who cannot join
- -
About this study
Official title: Care Pathways of Acute Heart Failure Patients: Impact on In-hospital Mortality. A French National Prospective Survey
The investigators conducted a prospective observational study to describe the different pre-hospital and in-hospital pathways of patients with acute heart failure (AHF) and their association with in-hospital mortality.
Read the detailed description
Prospective observational national multicentric study in 26 centres. Between june 2014 and october 2018 The investigators collected data about baseline characteristics, first recourse, in-hospital places of care and places of hospitalizations. Lengths of care and lengths of hospitalization.
Collected data of each patient were reported on a specific assessment tool. The investigators ran a univariate analysis and logistic regression between steps of the care pathway and in-hospital mortality. The main result was validated by an analysis with a propensity score: association between a hospitalization in cardiology and in-hospital mortality.
- Conditions
- Acute Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
Death of the patient during hospital stay reported by the physician in charge
Measured: Between patient's inclusion in the study and it's hospital discharge, up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study startJun 2014
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 3,677 participants (actual)
Sponsor and investigators
- Lead sponsor
- frederic ADNET
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, frederic ADNET, Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
- Investigators
- Frederic ADNET, MD, PhD, Principal investigator, Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03903198
- Sponsor's protocol ID
- 1836586v0
- Status last verified
- Apr 2019
- First submitted
- 28 Mar 2019
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cowie MR, Anker SD, Cleland JGF, Felker GM, Filippatos G, Jaarsma T, Jourdain P, Knight E, Massie B, Ponikowski P, Lopez-Sendon J. Improving care for patients with acute heart failure: before, during and after hospitalization. ESC Heart Fail. 2014 Dec;1(2):110-145. doi: 10.1002/ehf2.12021. Epub 2015 Jan 21.
PubMed 28834628Cleland JG, McDonagh T, Rigby AS, Yassin A, Whittaker T, Dargie HJ; National Heart Failure Audit Team for England and Wales. The national heart failure audit for England and Wales 2008-2009. Heart. 2011 Jun;97(11):876-86. doi: 10.1136/hrt.2010.209171. Epub 2010 Dec 20.
PubMed 21173198Gorlicki J, Boubaya M, Cottin Y, Angoulvant D, Soulat L, Guinemer S, Bloch-Queyrat C, Deltour S, Lambert Y, Juilliere Y, Adnet F. Patient care pathways in acute heart failure and their impact on in-hospital mortality, a French national prospective survey. Int J Cardiol Heart Vasc. 2019 Dec 5;26:100448. doi: 10.1016/j.ijcha.2019.100448. eCollection 2020 Feb.
PubMed 31867437
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Care Pathways of Acute Heart Failure Patients: Impact on In-hospital Mortality. A French National Prospective Survey
- ClinicalTrials.gov ID
- NCT03903198
- Acronym / sponsor ID
- 1836586v0
- Conditions
- Acute Heart Failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,677 participants (actual)
- Lead sponsor
- frederic ADNETUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Apr 2019 (actual)
- 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 investigators conducted a prospective observational study to describe the different pre-hospital and in-hospital pathways of patients with acute heart failure (AHF) and their association with in-hospital mortality.
Detailed description
Prospective observational national multicentric study in 26 centres. Between june 2014 and october 2018 The investigators collected data about baseline characteristics, first recourse, in-hospital places of care and places of hospitalizations. Lengths of care and lengths of hospitalization.
Collected data of each patient were reported on a specific assessment tool. The investigators ran a univariate analysis and logistic regression between steps of the care pathway and in-hospital mortality. The main result was validated by an analysis with a propensity score: association between a hospitalization in cardiology and in-hospital mortality.
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
- Patients hospitalized in 26 french hospitals for Acute Heart Failure
Key inclusion criteria (1 listed)
- All patients presenting to hospital with Acute Heart Failure according to the physician in care
Key exclusion criteria (1 listed)
- -
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
In-hospital mortality
Time frame: Between patient's inclusion in the study and it's hospital discharge, up to one year
Death of the patient during hospital stay reported by the physician in charge
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 4 Apr 2019.
- Background: PubMed 28834628Cowie MR, Anker SD, Cleland JGF, Felker GM, Filippatos G, Jaarsma T, Jourdain P, Knight E, Massie B, Ponikowski P, Lopez-Sendon J. Improving care for patients with acute heart failure: before, during and after hospitalization. ESC Heart Fail. 2014 Dec;1(2):110-145. doi: 10.1002/ehf2.12021. Epub 2015 Jan 21.
- Background: PubMed 21173198Cleland JG, McDonagh T, Rigby AS, Yassin A, Whittaker T, Dargie HJ; National Heart Failure Audit Team for England and Wales. The national heart failure audit for England and Wales 2008-2009. Heart. 2011 Jun;97(11):876-86. doi: 10.1136/hrt.2010.209171. Epub 2010 Dec 20.
- Derived from this study: PubMed 31867437Gorlicki J, Boubaya M, Cottin Y, Angoulvant D, Soulat L, Guinemer S, Bloch-Queyrat C, Deltour S, Lambert Y, Juilliere Y, Adnet F. Patient care pathways in acute heart failure and their impact on in-hospital mortality, a French national prospective survey. Int J Cardiol Heart Vasc. 2019 Dec 5;26:100448. doi: 10.1016/j.ijcha.2019.100448. eCollection 2020 Feb.
- Individual participant dataSharing planned: No
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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.
Frederic ADNET, MD, PhD principal investigator
Association pour le Développement de la Recherche et de l'Enseignement en Médecine d'Urgence
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure, run by frederic ADNET.
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 1 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 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
In-hospital mortality (time frame: Between patient's inclusion in the study and it's hospital discharge, up to one year). 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 NCT03903198, which also lists 3 linked publications.
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 4 Apr 2019.