Back to resultsManagement 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)
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Transmitral flow estimation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring bedside echography
Eligibility Criteria
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.
Sites / Locations
- CHU Arnaud de Villeneuve
- CHU Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
JET ECHO
NO JET ECHO
Arm Description
Transmitral flow estimation
no bedside echocardiography
Outcomes
Primary Outcome Measures
rehospitalization
Secondary Outcome Measures
mortality
worsening heart failure
average length of stay
alteration of biological parameters myocardial, kidney and liver
Full Information
NCT ID
NCT02892227
First Posted
August 26, 2016
Last Updated
August 5, 2019
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT02892227
Brief Title
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
Acronym
JECICA
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 15, 2016 (Actual)
Primary Completion Date
January 7, 2019 (Actual)
Study Completion Date
June 22, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
bedside echography
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JET ECHO
Arm Type
Experimental
Arm Description
Transmitral flow estimation
Arm Title
NO JET ECHO
Arm Type
No Intervention
Arm Description
no bedside echocardiography
Intervention Type
Procedure
Intervention Name(s)
Transmitral flow estimation
Intervention Description
Estimation of the transmitral flow of the inferior vena cava and its variations
Primary Outcome Measure Information:
Title
rehospitalization
Time Frame
30 days
Secondary Outcome Measure Information:
Title
mortality
Time Frame
6 months
Title
worsening heart failure
Time Frame
during hospitalization
Title
average length of stay
Time Frame
during hospitalization
Title
alteration of biological parameters myocardial, kidney and liver
Time Frame
Hospital discharge +7 days, Hospital discharge +30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
CHU Arnaud de Villeneuve
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
35407655
Citation
Ricci JE, Aguilhon S, Occean BV, Soullier C, Solecki K, Robert C, Huet F, Cornillet L, Schmutz L, Chevallier T, Akodad M, Leclercq F, Cayla G, Lattuca B, Roubille F. Impact of Daily Bedside Echocardiographic Assessment on Readmissions in Acute Heart Failure: A Randomized Clinical Trial. J Clin Med. 2022 Apr 6;11(7):2047. doi: 10.3390/jcm11072047.
Results Reference
derived
Learn more about this trial
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
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