NCT05056649

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 24, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

11 months

First QC Date

May 11, 2021

Last Update Submit

June 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quantitative analysis of verbatims after grouping

    Through study completion, an average of 1 year

Study Arms (1)

Heart Failure Patients with impaired ejection fraction

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patient who is a minor
  • Patient who does not have a general practitioner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU of Nancy

Vandœuvre-lès-Nancy, 54500, France

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Central Study Contacts

Jean-Marc BOIVIN, MD,PhD

CONTACT

Nicolas GIRERD, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 11, 2021

First Posted

September 24, 2021

Study Start

October 1, 2022

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Locations