NCT02892227

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 8, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

March 12, 2026

Status Verified

December 1, 2018

Enrollment Period

2.6 years

First QC Date

August 26, 2016

Last Update Submit

March 11, 2026

Conditions

Heart Failure

Keywords

bedside echography

Outcome Measures

Primary Outcomes (1)

  • rehospitalization

    30 days

Secondary Outcomes (4)

  • mortality

    6 months

  • worsening heart failure

    during hospitalization

  • average length of stay

    during hospitalization

  • alteration of biological parameters myocardial, kidney and liver

    Hospital discharge +7 days, Hospital discharge +30 days

Study Arms (2)

JET ECHO

EXPERIMENTAL

Transmitral flow estimation

Procedure: Transmitral flow estimation

NO JET ECHO

NO INTERVENTION

no bedside echocardiography

Interventions

Transmitral flow estimationPROCEDURE

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

JET ECHO

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The subject takes part in another 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Arnaud de Villeneuve

Montpellier, 34295, France

Location

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • 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.

    PMID: 35407655RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2016

First Posted

September 8, 2016

Study Start

November 15, 2016

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

March 12, 2026

Record last verified: 2018-12

Locations

FR(2)