Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2025-12-25 @ 8:56 PM
Study NCT ID:
NCT06181968
Status:
WITHDRAWN
Last Update Posted:
2024-03-07
First Post:
2023-12-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Treatment in Acute Heart Failure
Sponsor:
Kuopio University Hospital
Organization:
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI not workining at KUH anymore.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ECHO-AHF
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: