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

NCT ID: NCT02892227

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-15
• Study Completion Date: 2019-06-05

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.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JET ECHO

Transmitral flow estimation

Group Type: EXPERIMENTAL

Transmitral flow estimation

Intervention Type: PROCEDURE

Estimation of the transmitral flow of the inferior vena cava and its variations

NO JET ECHO

no bedside echocardiography

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Transmitral flow estimation

Estimation of the transmitral flow of the inferior vena cava and its variations

Intervention Type: PROCEDURE

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.

• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Arnaud de Villeneuve

Montpellier, , France

CHU Nimes

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 35407655 (View on PubMed)

Other Identifiers

2016-A00635-46

Identifier Type: OTHER

Identifier Source: secondary_id

AOI/2015/JER-01

Identifier Type: -

Identifier Source: org_study_id