Clinical trial NCT06181968: Ultrasound-guided Treatment in Acute Heart Failure
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Acute Heart Failure
Congestion
Keywords: Acute Heart Failure
Echocardiography
Lung Ultrasound
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled, blinded
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of patients with re-hospitalization or death
timeFrame: 6-months, also 3-months will be analyzed
measure: Number of patients with re-hospitalization
timeFrame: 6-months, also 3-months will be analyzed
Secondary outcomes:
measure: Number of patients with decongestion
timeFrame: during hospitalization
Other outcomes:
Locations:
Study officials:
References: