RecruitingNot ApplicableNCT04741711

AMBulatory UltraSound for Heart Failure Management

Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial

Sponsor

Central Hospital, Nancy, France

Enrollment

182 participants

Start Date

May 15, 2023

Study Type

INTERVENTIONAL

Conditions

Heart Failure

Summary

AMBUSH study is a multicenter randomized, controlled, open-label clinical trial (PROBE (Prospective Randomized Open Blinded End-point) type). The main objective of AMBUSH study is to assess the effect of therapeutic management guided by pulmonary ultrasound and the assessment of the inferior vena cava in patients with heart failure seen in an ambulatory (outpatient) setting on a mixed clinical-biological endpoint (including variations of natriuretic peptides - NtProBNP) at 30 days.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a small portable ultrasound device to check for fluid buildup in the lungs at home can help doctors better manage heart failure and prevent hospitalizations. **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of heart failure (any type) - Your heart failure was diagnosed more than 3 months ago - You are currently stable — no obvious signs of severe fluid buildup on your last exam - You have signed informed consent **You may NOT be eligible if...** - Your BNP or NT-proBNP levels are very high, suggesting acute decompensation - You have severe kidney disease on dialysis - You have a condition that makes ultrasound images unreliable (e.g., severe obesity or lung disease) - You are unable or unwilling to use the device at home Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREAn ultrasound (lung and inferior vena cava) will be performed and the heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava.

An ultrasound (lung and inferior vena cava) will be performed and the heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava. The choice of congestion treatment modalities to be implemented is left to the investigators' discretion, in accordance with European practice guidelines.

PROCEDUREUsual care without ultrasound guidance

Usual care (i.e. without ultrasound guidance)