Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04343443

Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation: Evaluation of Congestion at Hospital Discharge for Acute Heart Failure with Altered or Moderately Altered Ejection Fraction

Led by Central Hospital, Nancy, France · Updated on 2023-06-05

200

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients with acute heart failure who have reduced ejection fraction and are hospitalized for worsening heart failure. The study aims to identify markers of congestion—such as clinical signs, biological data, and ultrasound findings—at the time of hospital discharge that could be linked to the risk of death or rehospitalization within three months after leaving the hospital. Participants will undergo clinical exams focused on congestion, various Doppler ultrasounds of the heart and other organs, blood sample collection for biological tests and storage, and complete quality of life questionnaires. These evaluations take place before hospital discharge. Follow-up includes telephone interviews and quality of life assessments at 3, 12, and 24 months after discharge. During the study, participants will have clinical exams, ultrasounds, blood tests, and questionnaires before discharge, followed by phone interviews at set intervals to monitor their condition. Researchers will measure outcomes such as rates of death, rehospitalization, intravenous diuretic treatments, heart function class, kidney function, and quality of life over 24 months. This monitoring helps assess markers linked to heart failure outcomes over time.

CONDITIONS

Brief Title

Acute Heart Failure With Reduced Ejection Fraction - COngestion Discharge Evaluation

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients hospitalized for acute heart failure
  • Patients with reduced ejection fraction less than 40% or between 40% and 50%
  • Patients ready to be discharged from hospital for acute heart failure
  • Age 18 years or older
  • Patients who have received full information about the study and signed informed consent
  • Patients covered by a social security scheme
Not Eligible

You will not qualify if you...

  • Patients with other serious illnesses limiting life expectancy to 3 months or less
  • Patients on dialysis or with very low kidney function (glomerular filtration rate less than 15 ml/min/m2)
  • History of lung surgery such as lobectomy or pneumonectomy
  • Severe lung or pleural diseases preventing reliable lung ultrasound
  • Pregnant, breastfeeding, or recently giving birth
  • Adults under legal protection or unable to consent
  • People deprived of liberty by judicial or administrative order
  • Persons receiving psychiatric care under specific public health laws

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to hospital discharge

Participants undergo clinical examination centered on congestion, multiple Doppler ultrasounds, liver elastography, and blood sample collection before hospital discharge.

1 visit (in-person)

Long-term Monitoring

Duration - 24 months after hospital discharge

Participants are followed up through telephone interviews and quality of life questionnaires at 3, 12, and 24 months after hospital discharge.

Telephone interviews and questionnaires at 3, 12, and 24 months

Trial Site Locations

Total: 1 location

1

CHRU de Nancy

Vandœuvre-lès-Nancy, France, 54500

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Research Team

N

Nicolas GIRERD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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