- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05056649
The Role of the GP in the Management of Ambulatory Heart Failure (GPsHF)
June 20, 2023 updated by: Jean-Marc BOIVIN
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 Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jean-Marc BOIVIN, MD,PhD
- Phone Number: 33 3 83 15 73 11
- Email: jm.boivin@chru-nancy.fr
Study Contact Backup
- Name: Nicolas GIRERD, MD, PhD
- Phone Number: 33 383 5 7322
- Email: n.girerd@chru-nancy.fr
Study Locations
-
-
-
Vandœuvre-lès-Nancy, France, 54500
- Recruiting
- CHRU of Nancy
-
Contact:
- Jean-Marc BOIVIN, MD, PhD
-
Principal Investigator:
- Jean-Marc BOIVIN, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
|
Heart Failure Patients with impaired ejection fraction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quantitative analysis of verbatims after grouping
Time Frame: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2022
Primary Completion (Estimated)
September 1, 2023
Study Completion (Estimated)
September 1, 2023
Study Registration Dates
First Submitted
May 11, 2021
First Submitted That Met QC Criteria
September 23, 2021
First Posted (Actual)
September 24, 2021
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 20, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020PI049
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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