Acute Heart FailureECHO-AHFNCT06181968
Ultrasound-guided Treatment in Acute Heart Failure
A study testing Cardiothoracic ultrasound protocol in people with Acute Heart Failure and Congestion, run by Kuopio University Hospital.
Trial summary
A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Heart Failure, Congestion
- What is being tested?
- Cardiothoracic ultrasound protocol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 13 Mar 2019to 30 Nov 2020
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Multiple bilateral B-lines as a sign of interstitial syndrome on lung ultrasound
- Elevated natriuretic peptide level
- Signs of elevated LVEDP on echocardiography
- Dyspnea at rest or ortophnea
Who cannot join
- eGFR <25ml/min/1.73m2 or on dialysis
- Altered mental orientation
- Intubated
- Mitral stenosis or previous mitral valve procedure
- Chronic pulmonary parenchymal disease Pregnancy/breastfeeding
- Prisoners
- Patient under involuntary treatment
- Decision on study participation not made within 6 hours after receiving information regarding the study
About this study
Official title: Echocardiography and Lung Ultrasound Combined Into a Rapid Cardiothoracic Ultrasound Protocol (CaTUS) for Guiding Decongestive Treartment on a Day-to-day Basis in Patients Hospitalized for Acute Heart Failure With Pulmonary Congestion
A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.
Read the detailed description
Study overview:
The purpose of this study is to evaluate whether ultrasound-guided decongestive therapy, guided by a focused thoracic ultrasound protocol combining echocardiography and lung ultrasound, could result in better decongestion and post-discharge prognosis without lengthening hospitalizations in hospitalized Acute Heart Failure patients.
Primary objectives:
To test whether ultrasound-guided therapy could result in reduced 6-month post-discharge mortality rates or re-hospitalization rates
Secondary objectives:
To test whether ultrassound-guided therapy could result in greater decongestion as defined by various congestion parameters, i.e. ultrasound-derived cardiac filling pressures on echocardiography, pulmonary congestion on lung ultrasound, reduction in natriuretic peptides and symptoms, fluid loss etc, and if this can be done without an increase in adverse events or and increase in length of hospitalizations.
Study Design and population:
ECHO-AHF is a non-blinded, randomized trial which will be conducted in 3-5 centers across Europe. Patients entering the ED between 8 am and 5 pm, monday to friady, and who fulfill study criteria will be enrolled and randomized in a 1:1-fashion
Inclusion criteria will consist of: Age 18 years or older and dyspnea at rest or orthophnea, BNP >400ng/l or a BNP >100ng/l AND signs of elevated LVEDP on echocardiography and multiple bilateral B-lines on LUS,. Dyspnea on excertion will not be sufficient for enrolment.
Exclusion criteria will consist of: Pulmonary fibrosis, Mental confusion, Chronic dialysis, Pregnancy/breastfeeding, Prisoners, Patient under involuntary treatment, Decision on study participation not made within 6 hours after receiving information regarding the study.
Estimated population size based on power calculation will be approximately 120 patients in total.
Investigational therapy in the treatment group:
Patients randomized to the treatment arm will receive ultrasound-guided therapy based on a focused ultrasound exam done on a daily basis except for saturdays and sundays, and their treatment will be intensified according to a pre-specified, guideline-based treatment protocol, if the daily ultrasound protocol finds them congestive. Patients in the control arm will receive guideline-based conventional decongestive therapy.
- Conditions
- Acute Heart Failure, Congestion
- Being tested
- Cardiothoracic ultrasound protocol
- Keywords
- Acute Heart Failure, Echocardiography, Lung Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiothoracic ultrasound protocolDiagnostic test
Combined echocardiography and lung ultrasound for guiding therapy
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Active comparator | Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound Receives: Diagnostic Test: Cardiothoracic ultrasound protocol |
| Control Arm | Sham comparator | This arm will have the same ultrasound exams done daily as the treatment arm, but information will not be available for the treating physician for guiding therapy Receives: Diagnostic Test: Cardiothoracic ultrasound protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with re-hospitalization or death
post-discharge combined endpoint of re-hospitalization for acute heart failure or death due to any cause
Measured: 6-months, also 3-months will be analyzed
Number of patients with re-hospitalization
Post-discharge re-hospitalization due to acute heart failure
Measured: 6-months, also 3-months will be analyzed
Secondary outcomes (1)
Number of patients with decongestion
Decongestion as measured by multiple congestion parameters, i.e. reduction in cardiac filling pressures and pulmonary congestion on ultrasound, fluid/weight loss, reduction in natriuretic peptides, symptom improvement, length of hospitalization, adverse events
Measured: during hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start13 Mar 2019
- Primary completion30 Jun 2020
- Study completion30 Nov 2020
Why it stopped: PI not workining at KUH anymore.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled, blinded
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juha Hartikainen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181968
- Sponsor's protocol ID
- KUH5101120
- Acronym
- ECHO-AHF
- Status last verified
- Mar 2024
- First submitted
- 13 Dec 2023
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Echocardiography and Lung Ultrasound Combined Into a Rapid Cardiothoracic Ultrasound Protocol (CaTUS) for Guiding Decongestive Treartment on a Day-to-day Basis in Patients Hospitalized for Acute Heart Failure With Pulmonary Congestion
- ClinicalTrials.gov ID
- NCT06181968
- Acronym / sponsor ID
- ECHO-AHF / KUH5101120
- Conditions
- Acute Heart Failure, Congestion
- Keywords
- Acute Heart Failure, Echocardiography, Lung Ultrasound
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI not workining at KUH anymore.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 26 Dec 2023 (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.
A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.
Detailed description
Study overview:
The purpose of this study is to evaluate whether ultrasound-guided decongestive therapy, guided by a focused thoracic ultrasound protocol combining echocardiography and lung ultrasound, could result in better decongestion and post-discharge prognosis without lengthening hospitalizations in hospitalized Acute Heart Failure patients.
Primary objectives:
To test whether ultrasound-guided therapy could result in reduced 6-month post-discharge mortality rates or re-hospitalization rates
Secondary objectives:
To test whether ultrassound-guided therapy could result in greater decongestion as defined by various congestion parameters, i.e. ultrasound-derived cardiac filling pressures on echocardiography, pulmonary congestion on lung ultrasound, reduction in natriuretic peptides and symptoms, fluid loss etc, and if this can be done without an increase in adverse events or and increase in length of hospitalizations.
Study Design and population:
ECHO-AHF is a non-blinded, randomized trial which will be conducted in 3-5 centers across Europe. Patients entering the ED between 8 am and 5 pm, monday to friady, and who fulfill study criteria will be enrolled and randomized in a 1:1-fashion
Inclusion criteria will consist of: Age 18 years or older and dyspnea at rest or orthophnea, BNP >400ng/l or a BNP >100ng/l AND signs of elevated LVEDP on echocardiography and multiple bilateral B-lines on LUS,. Dyspnea on excertion will not be sufficient for enrolment.
Exclusion criteria will consist of: Pulmonary fibrosis, Mental confusion, Chronic dialysis, Pregnancy/breastfeeding, Prisoners, Patient under involuntary treatment, Decision on study participation not made within 6 hours after receiving information regarding the study.
Estimated population size based on power calculation will be approximately 120 patients in total.
Investigational therapy in the treatment group:
Patients randomized to the treatment arm will receive ultrasound-guided therapy based on a focused ultrasound exam done on a daily basis except for saturdays and sundays, and their treatment will be intensified according to a pre-specified, guideline-based treatment protocol, if the daily ultrasound protocol finds them congestive. Patients in the control arm will receive guideline-based conventional decongestive therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled, blinded
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Active comparator | Diagnostic Test: Cardiothoracic ultrasound protocolCongestive therapy will be guided by findings on daily cardiac- and lung ultrasound |
| Control Arm | Sham comparator | Diagnostic Test: Cardiothoracic ultrasound protocolThis arm will have the same ultrasound exams done daily as the treatment arm, but information will not be available for the treating physician for guiding therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Multiple bilateral B-lines as a sign of interstitial syndrome on lung ultrasound
- Elevated natriuretic peptide level
- Signs of elevated LVEDP on echocardiography
- Dyspnea at rest or ortophnea
Key exclusion criteria (8 listed)
- eGFR <25ml/min/1.73m2 or on dialysis
- Altered mental orientation
- Intubated
- Mitral stenosis or previous mitral valve procedure
- Chronic pulmonary parenchymal disease Pregnancy/breastfeeding
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 |
|---|---|---|
| Cardiothoracic ultrasound protocolCombined echocardiography and lung ultrasound for guiding therapy | Diagnostic test | Control Arm, Treatment arm |
Primary outcome
Number of patients with re-hospitalization or death
Time frame: 6-months, also 3-months will be analyzed
post-discharge combined endpoint of re-hospitalization for acute heart failure or death due to any cause
Number of patients with re-hospitalization
Time frame: 6-months, also 3-months will be analyzed
Post-discharge re-hospitalization due to acute heart failure
1 secondary outcome
Number of patients with decongestion
Time frame: during hospitalization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiothoracic ultrasound protocol in people with Acute Heart Failure and Congestion, run by Kuopio University Hospital.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 7 Mar 2024. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with re-hospitalization or death (time frame: 6-months, also 3-months will be analyzed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2024.