Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2019-03-13
2020-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Treatment arm
Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound
Cardiothoracic ultrasound protocol
Combined echocardiography and lung ultrasound for guiding therapy
Control Arm
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
Cardiothoracic ultrasound protocol
Combined echocardiography and lung ultrasound for guiding therapy
Interventions
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Cardiothoracic ultrasound protocol
Combined echocardiography and lung ultrasound for guiding therapy
Eligibility Criteria
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Inclusion Criteria
* Elevated natriuretic peptide level
* Signs of elevated LVEDP on echocardiography
* Dyspnea at rest or ortophnea
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Kuopio University Hospital
OTHER
Responsible Party
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Juha Hartikainen
Clinical Professor
Other Identifiers
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KUH5101120
Identifier Type: -
Identifier Source: org_study_id
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