Ultrasound-guided Treatment in Acute Heart Failure

Study Overview
=================
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.

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

Conditions
-----------------
Acute Heart Failure, Congestion

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiothoracic ultrasound protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled, blinded
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment arm<br>Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound | Diagnostic Test: Cardiothoracic ultrasound protocol<br>* Combined echocardiography and lung ultrasound for guiding therapy<br>|
| Sham Comparator: Control Arm<br>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 | Diagnostic Test: Cardiothoracic ultrasound protocol<br>* Combined echocardiography and lung ultrasound for guiding therapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Re-hospitalization | Post-discharge re-hospitalization due to acute heart failure | 6-months, also 3-months will be analyzed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Heart Failure, Echocardiography, Lung Ultrasound