Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04332692

Acute Heart Failure - COngestion Discharge Evaluation Evaluating Congestion at Hospital Discharge for Acute Heart Failure

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

110

Participants Needed

1

Research Sites

91 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Acute heart failure (AHF) is a serious health issue with a high risk of death or hospital readmission within three months after discharge. This risk increases when fluid buildup in the body is not adequately reduced by the end of the hospital stay, as measured by clinical scores, blood tests, or ultrasound scans. Although implantable devices can help guide treatment to reduce lung congestion, current methods to assess congestion lack standardization, making treatment adjustments mostly trial and error. This trial aims to find the best way to evaluate congestion in patients recovering from acute heart failure. Patients hospitalized for acute heart failure will receive several evaluations before discharge, including clinical exams focused on congestion and various Doppler ultrasounds of the heart, lungs, abdomen, neck veins, and kidneys, along with liver elastography. Blood samples will be taken for biological tests and storage. After leaving the hospital, participants will have telephone follow-ups at 3, 12, and 24 months. Quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire at discharge and during follow-up visits. Throughout the study, researchers will monitor outcomes such as death rates, hospital readmissions, and intravenous diuretic treatments at 3, 12, and 24 months after discharge. They will also assess heart function, kidney function, plasma volume, liver health, and patient quality of life. The study involves detailed clinical, imaging, and laboratory assessments to understand congestion better and how it relates to patient outcomes over a two-year period.

CONDITIONS

Brief Title

Acute Heart Failure - 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 considered clinically ready to be discharged from hospital for acute heart failure
  • Age 18 years or older
  • Patients who have received complete information about the study and signed informed consent
  • Patients affiliated with or beneficiaries of a social security scheme
Not Eligible

You will not qualify if you...

  • Life expectancy of 3 months or less due to comorbid conditions
  • Patients on dialysis (peritoneal or hemodialysis) or with glomerular filtration rate below 15 ml/min/m2 at inclusion
  • History of lobectomy or pneumonectomy lung surgery
  • Severe pulmonary or pleural diseases preventing reliable lung ultrasound imaging, such as severe emphysema, chronic pleurisy, or pulmonary fibrosis
  • Pregnant women, women in labor, or breastfeeding mothers
  • Adults under legal protection measures (guardianship, curatorship, or safeguard of justice)
  • Adults unable to give consent
  • Individuals deprived of liberty by judicial or administrative decision
  • Persons receiving psychiatric care under specific public health code articles

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 examinations focusing on congestion, including cardiac, pulmonary, peritoneal, jugular, and renal Doppler ultrasounds, liver elastography, and blood sample collection before hospital discharge.

1 visit (in-person) before discharge

Long-term Monitoring

Duration - 24 months after discharge

Participants receive telephone follow-ups and complete quality of life questionnaires at 3, 12, and 24 months after hospital discharge to monitor their health status.

3 telephone follow-up calls at 3, 12, and 24 months

Trial Site Locations

Total: 1 location

1

CHRU de Nancy

Vandœuvre-lès-Nancy, France, 54500

Actively Recruiting

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Research Team

N

Nicolas GIRERD, MD,PhD

S

Sanae BOUALI, PhD

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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