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

Heart Failure Clinical Trial

— JECICA  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02892227
• Other study ID #: AOI/2015/JER-01
• Status: Completed
• Phase: N/A
• Start date: November 15, 2016
• Est. completion date: June 22, 2019

Study information

• Verified date: December 2018
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 22, 2019
• Est. primary completion date: January 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

Procedure:
• Transmitral flow estimation
Estimation of the transmitral flow of the inferior vena cava and its variations

Locations

Country	Name	City	State
France	CHU Arnaud de Villeneuve	Montpellier
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rehospitalization		30 days
Secondary	mortality		6 months
Secondary	worsening heart failure		during hospitalization
Secondary	average length of stay		during hospitalization
Secondary	alteration of biological parameters myocardial, kidney and liver		Hospital discharge +7 days, Hospital discharge +30 days