Evaluation of lung ultrasound as a guiding tool for treatment adjustment in patients with heart failure admitted to hospital
| ISRCTN | ISRCTN95766678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95766678 |
- Submission date
- 15/03/2022
- Registration date
- 21/03/2022
- Last edited
- 05/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Heart failure means that the heart is unable to pump blood around the body properly. It usually occurs because the heart has become too weak or stiff.
Lung congestion (a condition caused by excess fluid in the lungs) can be evaluated with lung ultrasound (a procedure that uses high-frequency sound waves to create an image of part of the inside of the body) in patients with heart failure.
The aim of this study is to evaluate if lung ultrasound may guide heart failure treatment improving clinical outcomes (survival or the need of intravenous diuretics).
Who can participate?
Adult patients with heart failure.
What does the study involve?
Participants will receive heart failure treatment (above all diuretic treatment) guided by lung ultrasound lung congestion results or following standard of care management using physical examination. Clinical outcomes will be registered during 6 months.
What are the possible benefits and risks of participating?
The benefit is to obtain better outcomes like less mortality or less readmission rate. Risks are related to an excess of diuretic doses that may generate hypotension or renal failure.
Where is the study run from?
Sociedad Española de Medicina Interna (Spain)
When is the study starting and how long is it expected to run for?
September 2017 to March 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Juan Torres-Macho, juan.torresm@salud.madrid.org
Contact information
Principal Investigator
C/ Gran Vía del Este, 80
Madrid
28031
Spain
 ORCID ID |
0000-0002-8860-6837 |
|---|---|
| Phone | +34 9119138000 |
| juan.torresm@salud.madrid.org |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Effect of a therapeutic strategy guided by lung ultrasound on 6-month outcomes in patients with heart failure. The EPICC trial |
| Study acronym | EPICC |
| Study objectives | Pulmonary congestion (PC) is associated with an increased risk of hospitalization and death in patients with heart failure (HF). Lung ultrasound has shown to be highly sensitive for detecting PC in HF. The aim of this study is to evaluate whether lung ultrasound-guided therapy improves 6-month outcomes in patients with HF compared with conventional treatment. |
| Ethics approval(s) | Approved 25/02/2019, CEIm Hospital Universitario Puerta de Hierro (C/ Joaquín Rodrigo, 2. 28222 Majadahonda, Madrid, Spain; +34 91 191 60 00; no email provided), ref: 28981 |
| Health condition(s) or problem(s) studied | Heart failure |
| Intervention | Randomized, multicenter, single-blind clinical trial in patients discharged from Internal Medicine Departments after hospitalization for decompensated HF. Randomization was performed via an online tool. Participants were assigned 1:1 to receive treatment guided according to the presence of lung ultrasound signs of congestion (semi-quantitative evaluation of B lines and the presence of pleural effusion) versus clinical assessment of congestion (standard of care). Participants were followed up for 6 months. |
| Intervention type | Other |
| Primary outcome measure | Cardiovascular death, admission due to heart failure, emergency department visit due to heart failure, diuretic administration at day hospital measured using patient records at 6 months |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2017 |
| Completion date | 01/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 152 |
| Total final enrolment | 79 |
| Key inclusion criteria | 1. Age older than 18 y 2. NYHA functional class ≥II at inclusion 3. Able to attend ambulatory follow-up visits |
| Key exclusion criteria | 1. Life expectancy <6 months due to a different medical condition than HF 2. Heart transplantation 3. Acute coronary syndrome 4. Recent coronary revascularization 5. Valve replacement or resynchronization in the prior 3 months 6. Pregnancy 7. Restrictive pulmonary disease or severe COPD needing continuous oxygen 8. Serum creatinine >3 mg/dl or chronic renal insufficiency in dialysis 9. Severe valve stenosis 10. Participation in another randomized study |
| Date of first enrolment | 01/09/2018 |
| Date of final enrolment | 01/09/2020 |
Locations
Countries of recruitment
- Spain
Study participating centres
28981
Spain
28040
Spain
06300
Spain
03314
Spain
28034
Spain
27003
Spain
Sponsor information
Research organisation
Pintor Ribera, 3
Madrid
28016
Spain
| Phone | +34 91 519 70 80 |
|---|---|
| semi@fesemi.org | |
| Website | https://www.fesemi.org/ |
"ROR" |
https://ror.org/0031gef94 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/05/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the publication of the subsequent results |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 22/07/2019 | 18/03/2022 | Yes | No | |
| Results article | results | 22/08/2022 | 05/04/2023 | Yes | No |
Editorial Notes
05/04/2023: Publication reference added.
18/03/2022: Trial's existence confirmed by CEIm Hospital Universitario Puerta de Hierro
