Clinical trial NCT02892227: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: bedside echography
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2016-09-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: rehospitalization
timeFrame: 30 days
Secondary outcomes:
measure: mortality
timeFrame: 6 months
measure: worsening heart failure
timeFrame: during hospitalization
measure: average length of stay
timeFrame: during hospitalization
measure: alteration of biological parameters myocardial, kidney and liver
timeFrame: Hospital discharge +7 days, Hospital discharge +30 days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
References:
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.