Ultrasound-guided Treatment in Acute Heart Failure (ECHO-AHF)

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

A randomized non-blinded study comparing ultrasound-guided therapy with conventional therapy in acute heart failure patients.

Study Overview

• Status: Withdrawn
• Conditions: Acute Heart Failure; Congestion
• Intervention / Treatment: Diagnostic test: Cardiothoracic ultrasound protocol

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.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment arm; Congestive therapy will be guided by findings on daily cardiac- and lung ultrasound	Diagnostic test: Cardiothoracic ultrasound protocol; Combined echocardiography and lung ultrasound for guiding therapy
Sham Comparator: 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	Diagnostic test: Cardiothoracic ultrasound protocol; Combined echocardiography and lung ultrasound for guiding therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kuopio University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): November 30, 2020

Study Registration Dates

• First Submitted: December 13, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Echocardiography; Acute Heart Failure; Lung Ultrasound
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: KUH5101120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No