Using ultrasound to manage heart failure in outpatient settings
Impact of Ultrasound-guided Therapeutic Management of Ambulatory Patients With Heart Failure : An Open-label Randomized Clinical Trial
NA · Central Hospital, Nancy, France · NCT04741711
This study is testing if using ultrasound to guide treatment can help people with heart failure do better than those who get standard care without ultrasound.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 182 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France (other) |
| Locations | 5 sites (Besançon and 4 other locations) |
| Trial ID | NCT04741711 on ClinicalTrials.gov |
What this trial studies
The AMBUSH study is a multicenter, randomized, controlled clinical trial that aims to evaluate the effectiveness of therapeutic management guided by pulmonary ultrasound and inferior vena cava assessment in patients with heart failure. Participants will be monitored for changes in natriuretic peptides and clinical outcomes over a 30-day period. The study will compare the outcomes of patients receiving ultrasound-guided treatment to those receiving standard care without ultrasound. Secondary objectives include assessing the risk of cardiovascular events and the relationship between ultrasound findings and serum biomarker levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over with a diagnosis of heart failure established for more than three months and no significant clinical signs of congestion.
Not a fit: Patients with recent natriuretic peptide results, significant pulmonary pathology, or severe heart valve disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of heart failure, reducing hospitalizations and cardiovascular deaths.
How similar studies have performed: Similar studies utilizing ultrasound for heart failure management have shown promising results, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged 18 and over * Heart failure (regardless of left ventricular ejection fraction) * Diagnosis of heart failure established more than 3 months ago * Absence of significant clinical signs of congestion on clinical examination (absence of crackles and lower limbs oedema greater than perimalleolar oedema) * Affiliation to social security * Receiving complete information about research organization and signed informed consent. Exclusion Criteria: * Natriuretic peptides result, carried out during the previous 30 days, available at the inclusion consultation * Pulmonary or pleural pathology preventing reliable acquisition of lung ultrasound images: severe emphysema, chronic pleurisy, pulmonary fibrosis. * Suspicion of cardiac amyloidosis or proven amyloidosis, * Patient with severe primary heart valve disease * Pregnant woman, parturient or nursing mother * Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice) * Person deprived of liberty by a judicial or administrative decision, * Person subject to psychiatric care pursuant to Articles L. 3212-1 and L. 3213-1 of the Public Health Code.
Where this trial is running
Besançon and 4 other locations
- CHU de Besançon — Besançon, France (NOT_YET_RECRUITING)
- CH de Mulhouse — Mulhouse, France (NOT_YET_RECRUITING)
- CHRU de Reims — Reims, France (NOT_YET_RECRUITING)
- CHR de Metz — Thionville, France (NOT_YET_RECRUITING)
- CHRU de Nancy — Vandœuvre-lès-Nancy, France (RECRUITING)
Study contacts
- Study coordinator: Nicolas GIRERD, MD,PhD
- Email: n.girerd@chru-nancy.fr
- Phone: +33 3 83 15 74 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure