NCT04845126

Brief Summary

In 2018, the investigators evaluated the treatment of 236 patients with heart failure (with preserved or reduced ejection fraction) before and after hospitalization in our internal medicine unit (from 2016 to 2017). The investigators showed that patients, mainly elderly women with comorbidities, often had suboptimal heart failure treatment without an identified cause. The investigators tried, whenever possible, to optimize treatment before hospital discharge. Our objective is now to analyze the 4-year outcome of these patients, including re-hospitalization for heart failure or death.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2021

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2021

Completed
Last Updated

April 14, 2022

Status Verified

April 1, 2022

Enrollment Period

1 month

First QC Date

April 13, 2021

Last Update Submit

April 13, 2022

Conditions

Heart Failure

Keywords

OutcomesInternal medecineHeart failure treatmentHeart failure guidelinesquality of life

Outcome Measures

Primary Outcomes (1)

  • re-hospitalization for heart failure or death failure assessed by spirometry

    re-hospitalization for heart failure or death (yes or no) (composite outcome)

    1 day

Secondary Outcomes (4)

  • time to re-hospitalization

    1 day

  • time to death

    1 day

  • cause of hospitalization

    1 day

  • cause of death

    1 day

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized for heart failure or with known heart failure in our Internal Medecine unit between 2016/01/01 and 2018/01/01.

You may qualify if:

  • \- Patients hospitalized in our Internal Medecine unit for acute heart failure or for another cause but with known chronic heart Failure

You may not qualify if:

  • \- Hemodilaysis, end stage kidney disease, heart failure cause by anuria, heart transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Pierre Fesler, PUPH

    UH MONTPELLIER

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2021

First Posted

April 14, 2021

Study Start

March 1, 2021

Primary Completion

April 1, 2021

Study Completion

December 25, 2021

Last Updated

April 14, 2022

Record last verified: 2022-04

Locations

FR(1)