Acute Heart FailureEPPICANCT04633629
LUS in Acute Heart Failure Therapeutic Adaptation
An observational study of Acute Heart Failure and Pulmonary Congestion, run by University Hospital, Grenoble.
Trial summary
Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Pulmonary Congestion
- What is being tested?
- Lung ultrasound
- How many people
- 94 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged over 18, hospitalized from the emergency department in the medical department for acute heart failure.
Who may be able to join
- 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.
Who cannot join
- Administrative supervision or deprived of their liberty
- Pulmonary conditions distracting lung ultrasound (pneumonectomy, pulmonary fibrosis)
- Chronically dialysed
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Interest of Lung Ultrasound (LUS) in Therapeutic Adaptation of Patients Hospitalized in Medical Department for Acute Heart Failure (AHF).
Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.
Read the detailed description
EPPICA is an observational and prospective cohort study. The study goal is to evaluate LUS aspect evolution according to diuretics dosage in patients hospitalized for acute heart failure.
- Conditions
- Acute Heart Failure, Pulmonary Congestion
- Being tested
- Lung ultrasound
- Keywords
- Lung Ultrasound, Diuretics, Medical department
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasoundOther
We will perform daily a lung ultrasound to evaluate pulmonary congestion by counting B-lines.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute heart failure | Patients hospitalized for acute heart failure in medical department. Receives: Other: Lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung ultrasound aspect according to diuretics dosage evolution.
B-lines number on LUS
Measured: 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)
B-lines number on LUS
Measured: 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).
B-lines number on LUS
Measured: 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)
B-lines number on LUS
Measured: 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.
Number of LUS performed compared to number of hospitalisation days.
Measured: LUS will be performed daily during the whole hospitalisation length (on average 7 days).
Interest of LUS compared to clinical examination at discharge.
B-lines at discharge compared to clinical signs of acute heart failure.
Measured: LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2020
- Study startDec 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionOct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Perrine Dumanoir, Doctor, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04633629
- Sponsor's protocol ID
- 38RC20.328
- Other IDs
- 2020-A02413-36
- Acronym
- EPPICA
- Status last verified
- Nov 2020
- First submitted
- 8 Sep 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28960894Coiro 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.
PubMed 26417699Gargani 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.
PubMed 26337295Platz 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.
PubMed 28557302Volpicelli 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.
PubMed 18534289Rusu 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.
PubMed 31023358
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Lung Ultrasound (LUS) in Therapeutic Adaptation of Patients Hospitalized in Medical Department for Acute Heart Failure (AHF).
- ClinicalTrials.gov ID
- NCT04633629
- Acronym / sponsor ID
- EPPICA / 38RC20.328
- Conditions
- Acute Heart Failure, Pulmonary Congestion
- Keywords
- Lung Ultrasound, Diuretics, Medical department
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 18 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate lung ultrasound aspect according to diuretics dosage evolution in patients hospitalized for acute heart failure.
Detailed description
EPPICA is an observational and prospective cohort study. The study goal is to evaluate LUS aspect evolution according to diuretics dosage in patients hospitalized for acute heart failure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute heart failure | – | Other: Lung ultrasoundPatients hospitalized for acute heart failure in medical department. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged over 18, hospitalized from the emergency department in the medical department for acute heart failure.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Administrative supervision or deprived of their liberty
- Pulmonary conditions distracting lung ultrasound (pneumonectomy, pulmonary fibrosis)
- Chronically dialysed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung ultrasoundWe will perform daily a lung ultrasound to evaluate pulmonary congestion by counting B-lines. | Other | Patients with acute heart failure |
Primary outcome
Lung ultrasound aspect according to diuretics dosage evolution.
Time frame: LUS will be performed daily during the whole hospitalisation length (on average 7 days).
B-lines number on LUS
5 secondary outcomes
Lung ultrasound aspect according to clinical signs of acute heart failure (crackling auscultation or lower limbs edema)
Time frame: 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).
Time frame: 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)
Time frame: 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.
Time frame: LUS will be performed daily during the whole hospitalisation length (on average 7 days).
Interest of LUS compared to clinical examination at discharge.
Time frame: LUS and clinical examination will be performed daily during the whole hospitalisation length (on average 7 days).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Background: PubMed 28960894Ohman 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.
- Background: PubMed 26417699Coiro 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.
- Background: PubMed 26337295Gargani 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.
- Background: PubMed 28557302Platz 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.
- Background: PubMed 18534289Volpicelli 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.
- Background: PubMed 31023358Rusu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Perrine Dumanoir, Doctor principal investigator
University Hospital, Grenoble
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and Pulmonary Congestion, run by University Hospital, Grenoble.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Perrine Dumanoir, Doctor (+33476767098, pdumanoir@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung ultrasound aspect according to diuretics dosage evolution. (time frame: LUS will be performed daily during the whole hospitalisation length (on average 7 days).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04633629, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020; AzTrials last refreshed its copy on 6 Nov 2026.