NCT04633629

Brief Summary

Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Shorter than P25 for all trials

Status
unknown

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

September 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

September 8, 2020

Last Update Submit

November 12, 2020

Conditions

Keywords

Lung UltrasoundDiureticsMedical department

Outcome Measures

Primary Outcomes (1)

  • Lung ultrasound aspect according to diuretics dosage evolution.

    B-lines number on LUS

    LUS will be performed daily during the whole hospitalisation length (on average 7 days).

Secondary Outcomes (5)

  • Lung ultrasound aspect according to clinical signs of acute heart failure (crackling auscultation or lower limbs edema)

    LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).

  • Lung ultrasound aspect according to acute kidney injury (based on plasmatic creatinine levels).

    LUS will be performed daily during the whole hospitalisation length (on average 7 days). Plasmatic creatinine measure will be performed at least weekly.

  • Lung ultrasound aspect according to early prognosis (re-hospitalisation or mortality within 30 days after discharge)

    LUS will be performed daily during the whole hospitalisation length (on average 7 days). Patient will be called 30 days after discharge.

  • Feasibility of daily LUS in medical department.

    LUS will be performed daily during the whole hospitalisation length (on average 7 days).

  • Interest of LUS compared to clinical examination at discharge.

    LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).

Study Arms (1)

Patients with acute heart failure

Patients hospitalized for acute heart failure in medical department.

Other: Lung ultrasound

Interventions

We will perform daily a lung ultrasound to evaluate pulmonary congestion by counting B-lines.

Patients with acute heart failure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged over 18, hospitalized from the emergency department in the medical department for acute heart failure.

You may qualify if:

  • Acute heart failure diagnosed by a senior physician in the medical department, with a confirmation of a second senior physician.
  • Hospitalised in the medical department.
  • No objection from the patient of his trusted person.

You may not qualify if:

  • Administrative supervision or deprived of their liberty
  • Pulmonary conditions distracting lung ultrasound (pneumonectomy, pulmonary fibrosis)
  • Chronically dialysed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Ohman J, Harjola VP, Karjalainen P, Lassus J. Focused echocardiography and lung ultrasound protocol for guiding treatment in acute heart failure. ESC Heart Fail. 2018 Feb;5(1):120-128. doi: 10.1002/ehf2.12208. Epub 2017 Sep 28.

    PMID: 28960894BACKGROUND
  • Coiro S, Rossignol P, Ambrosio G, Carluccio E, Alunni G, Murrone A, Tritto I, Zannad F, Girerd N. Prognostic value of residual pulmonary congestion at discharge assessed by lung ultrasound imaging in heart failure. Eur J Heart Fail. 2015 Nov;17(11):1172-81. doi: 10.1002/ejhf.344. Epub 2015 Sep 29.

    PMID: 26417699BACKGROUND
  • Gargani L, Pang PS, Frassi F, Miglioranza MH, Dini FL, Landi P, Picano E. Persistent pulmonary congestion before discharge predicts rehospitalization in heart failure: a lung ultrasound study. Cardiovasc Ultrasound. 2015 Sep 4;13:40. doi: 10.1186/s12947-015-0033-4.

    PMID: 26337295BACKGROUND
  • Platz E, Merz AA, Jhund PS, Vazir A, Campbell R, McMurray JJ. Dynamic changes and prognostic value of pulmonary congestion by lung ultrasound in acute and chronic heart failure: a systematic review. Eur J Heart Fail. 2017 Sep;19(9):1154-1163. doi: 10.1002/ejhf.839. Epub 2017 May 30.

    PMID: 28557302BACKGROUND
  • Volpicelli G, Caramello V, Cardinale L, Mussa A, Bar F, Frascisco MF. Bedside ultrasound of the lung for the monitoring of acute decompensated heart failure. Am J Emerg Med. 2008 Jun;26(5):585-91. doi: 10.1016/j.ajem.2007.09.014.

    PMID: 18534289BACKGROUND
  • Rusu DM, Siriopol I, Grigoras I, Blaj M, Ciumanghel AI, Siriopol D, Nistor I, Onofriescu M, Sandu G, Cobzaru B, Scripcariu DV, Diaconu O, Covic AC. Lung Ultrasound Guided Fluid Management Protocol for the Critically Ill Patient: study protocol for a multi-centre randomized controlled trial. Trials. 2019 Apr 25;20(1):236. doi: 10.1186/s13063-019-3345-0.

    PMID: 31023358BACKGROUND

Study Officials

  • Perrine Dumanoir, Doctor

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Perrine Dumanoir, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2020

First Posted

November 18, 2020

Study Start

December 1, 2020

Primary Completion

May 1, 2021

Study Completion

October 1, 2021

Last Updated

November 18, 2020

Record last verified: 2020-11