Management of Acute Heart Failure: Contribution of Ultrasound Daily "in Bed Patient" Adjustment on Therapy With Impact Measure on re Hospital Rate During 30 Days (JECICA)

August 5, 2019 updated by: Centre Hospitalier Universitaire de Nīmes

Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and reproducible estimation of filling pressures with an evaluation of mitral inflow and the inferior vena cava, allow a more reliable estimate of the true blood volume of the patient and thus lead to a therapeutic adjustment more suitable.

This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30 days and mortality, less alteration of biological parameters myocardial, kidney and liver.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • CHU Arnaud de Villeneuve
      • Nîmes, France, 30029
        • CHU Nîmes

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

The patient or his representative must be given free and informed consent and signed consent.

  • The patient must be affiliated or beneficiary of a health insurance plan.
  • The patient is available for a follow-up 6 months.
  • The patient is of age or older (>) 18.
  • Patients hospitalized for acute heart failure who received at least 40mg of furosemide IV.
  • Patient with impaired LVEF <50%.
  • Patient with Nt-proBNP values> 1200pg / ml.

Exclusion Criteria:

  • The subject takes part in another study.

    • The subject is exclusion period determined by a previous study.
    • The subject is under judicial protection.
    • The subject or his representative refuses to sign the consent.
    • It is not possible to give the subject or his representative informed information.

Non-inclusion criteria for those diseases or conditions associated (s) interfere (s):

  • The patient is pregnant or is breastfeeding.
  • The patient is already included in a surveillance program (PRADO, OSICAT).
  • Patient with a mechanical or biological mitral prosthesis.
  • History of mitral stenosis.
  • severe valvular surgery with maturity in months (<30 days).
  • chronic renal impairment on dialysis.
  • High grade AV block (AVB and BAV3 2/1).
  • Hypertrophic cardiomyopathy.
  • Cardiogenic shock.
  • Contraindications to furosemide.

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JET ECHO
Transmitral flow estimation
Procedure: Transmitral flow estimation
Estimation of the transmitral flow of the inferior vena cava and its variations
No Intervention: NO JET ECHO
no bedside echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rehospitalization
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality
Time Frame: 6 months
6 months
worsening heart failure
Time Frame: during hospitalization
during hospitalization
average length of stay
Time Frame: during hospitalization
during hospitalization
alteration of biological parameters myocardial, kidney and liver
Time Frame: Hospital discharge +7 days, Hospital discharge +30 days
Hospital discharge +7 days, Hospital discharge +30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 15, 2016

Primary Completion (Actual)

January 7, 2019

Study Completion (Actual)

June 22, 2019

Study Registration Dates

First Submitted

August 26, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 8, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOI/2015/JER-01

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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