Heart FailureGPsHFNCT05056649
The Role of the GP in the Management of Ambulatory Heart Failure
An observational study of Heart Failure, run by Jean-Marc BOIVIN at 1 site in France.
Trial summary
To describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ARS blockers of the type ACEinhibitor/ARA2/ARNi, ß- and/or anti-aldosterone). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2022to 1 Sep 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart failure patients with impaired ejection fraction (LVEF < 40%), under 85 years of age, admitted to the emergency department for cardiac decompensation and hospitalised in the aftermath of this decompensation, for whom the sum of the doses of ACE inhibitor or ARB2 + BB + aldosterone antagonist is less than 50% of the dose required for this patient
Who may be able to join
- Patients with a previous diagnosis of heart failure with impaired ejection fraction (LVEF < 40%)
- Under 85 years of age
- Admitted to an Emergency department for cardiac decompensation
- Hospitalized following this decompensation
- Not deceased within one month of hospitalisation
- Whose sum of the doses of ACEI or ARB2 + BB + aldosterone antagonist is less than 50% of the dose required for this patient* (definition in annex)
Show all 10Show fewer
- Who did not object within one month of being informed
- Exclusion Criteria:- Patient objecting to the use of their data
- Patient who is a minor
- Patient who does not have a general practitioner
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU of Nancy
Vandœuvre-lès-Nancy, 54500
Jean-Marc BOIVIN, MD, PhD
Jean-Marc BOIVIN, MD, PhD
About this study
To describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ARS blockers of the type ACEinhibitor/ARA2/ARNi, ß- and/or anti-aldosterone).
- Conditions
- Heart Failure
- Medical subject headings
- Heart Failure
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 |
|---|---|---|
| Heart Failure Patients with impaired ejection fraction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative analysis of verbatims after grouping
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start1 Oct 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jean-Marc BOIVIN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jean-Marc BOIVIN, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056649
- Sponsor's protocol ID
- 2020PI049
- Acronym
- GPsHF
- Status last verified
- Jun 2023
- First submitted
- 11 May 2021
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the GP in the Management of Ambulatory Heart Failure
- ClinicalTrials.gov ID
- NCT05056649
- Acronym / sponsor ID
- GPsHF / 2020PI049
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jean-Marc BOIVINUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 Sep 2021 (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.
To describe the causes mentioned by general practitioners, explaining the under-treatment of the three main treatments for heart failure with impaired ejection fraction (ARS blockers of the type ACEinhibitor/ARA2/ARNi, ß- and/or anti-aldosterone).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients with impaired ejection fraction | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart failure patients with impaired ejection fraction (LVEF < 40%), under 85 years of age, admitted to the emergency department for cardiac decompensation and hospitalised in the aftermath of this decompensation, for whom the sum of the doses of ACE inhibitor or ARB2 + BB + aldosterone antagonist is less than 50% of the dose required for this patient
Key inclusion criteria (10 listed)
- Patients with a previous diagnosis of heart failure with impaired ejection fraction (LVEF < 40%)
- Under 85 years of age
- Admitted to an Emergency department for cardiac decompensation
- Hospitalized following this decompensation
- Not deceased within one month of hospitalisation
Key exclusion criteria (0 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
Quantitative analysis of verbatims after grouping
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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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.
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 Heart Failure, run by Jean-Marc BOIVIN 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 10 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 22 Jun 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc BOIVIN, MD,PhD (3 83 15 73 11 ext. 33, jm.boivin@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative analysis of verbatims after grouping (time frame: Through study completion, an average of 1 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 22 Jun 2023.