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PI not workining at KUH anymore.
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A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Active Comparator | Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiothoracic ultrasound protocol | Diagnostic Test | Combined echocardiography and lung ultrasound for guiding therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 6-months, also 3-months will be analyzed |
| Number of patients with re-hospitalization | Post-discharge re-hospitalization due to acute heart failure | 6-months, also 3-months will be analyzed |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | during hospitalization |
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Inclusion Criteria:
Exclusion Criteria:
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Randomized controlled, blinded
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Only the treating physician on the ward will know which arm the patient belongs to