Using dobutamine stress echocardiography to improve diagnosis of aortic stenosis in patients with cardiac amyloidosis

Utility of Dobutamine Stress Echocardiography in the Diagnosis of Severe Aortic Stenosis in Patients With Low-flow Low-gradient and Co-exiting Wild-type Transthyretin Amyloid Cardiomyopathy

This study is testing if a special heart ultrasound called dobutamine stress echocardiography can help better diagnose aortic stenosis in patients with a specific type of heart condition caused by amyloidosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Aarhus University Hospital Skejby (Academic / other)
• Locations: 1 site (Aarhus)
• Trial ID: NCT06372301 on ClinicalTrials.gov

What this trial studies

This clinical study aims to enhance the diagnosis of low-flow low-gradient aortic stenosis (LF/LG AS) in patients with wild-type transthyretin cardiac amyloidosis (ATTRwt). It will compare the effectiveness of dobutamine stress echocardiography against the gold standard of invasively measured aortic valve area. Participants will undergo a series of assessments including echocardiography, catheterization, and cardiac magnetic resonance imaging to evaluate heart function and structure. The study will also investigate the relationship between myocardial fibrosis, amyloid infiltration, and aortic stenosis severity.

Who should consider this trial

Good fit: Ideal candidates are symptomatic patients aged 65 and older with confirmed ATTRwt and low-flow low-gradient aortic stenosis.

Not a fit: Patients with significant other valvular diseases or severe coronary artery diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate diagnoses and better management of patients with aortic stenosis and cardiac amyloidosis.

How similar studies have performed: While the use of dobutamine stress echocardiography is established, this specific application in ATTRwt patients with LF/LG AS is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. ATTRwt, diagnosis confirmed by 99mtc-3,3-Diphosphono-1,2-Propanodicarboxylic Acid (DPD) scintigraphy, genetic testing, and/or endomyocardial biopsy.
2. Symptomatic patients (New York Heart Association \> class I) treated with loop diuretics.
3. LF/LG AS: Defined as, aortic valve area ≤ 1 cm2 and mean gradient \< 40 mmHg, and SVI ≤35 ml/m2.
4. Age ≥ 65 years.
5. Oral and written informed consent.

Exclusion Criteria:

1. Other significant valvular disease.
2. Known severe coronary artery diseases: left main stem stenosis or 3-vessel disease, or recent acute myocardial infarction (\< 4 weeks).
3. Contraindications to the use of dobutamine: Known allergy to dobutamine or sulfite, phaeochromocytoma or ventricular tachycardia (VT).

Where this trial is running

Aarhus

• Department of Cardiology, Aarhus University Hospital — Aarhus, Denmark (Recruiting)

Study contacts

• Study coordinator: Ali Hussein Jaber Mejren

Conditions Transthyretin Amyloid Cardiomyopathy; Aortic Stenosis; ATTR-CM; wild-type cardiac amyloidosis; aortic stenosis; low-flow low-gradient aortic stenosis; Dobutamine