Acute Heart Failure, Congestion
Conditions
Keywords
Acute Heart Failure, Echocardiography, Lung Ultrasound
Brief summary
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.
Interventions
DIAGNOSTIC_TESTCardiothoracic ultrasound protocol
Combined echocardiography and lung ultrasound for guiding therapy
Sponsors
Kuopio University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the treating physician on the ward will know which arm the patient belongs to
Intervention model description
Randomized controlled, blinded
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with re-hospitalization or death | 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 | 6-months, also 3-months will be analyzed | Post-discharge re-hospitalization due to acute heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with decongestion | during hospitalization | 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 |
Outcome results
None listed