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Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)

RecruitingPhase 1, Phase 2Ages 65 Years - anyAllSteen Hvitfeldt Poulsen
NCT06318260 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine, in patients with wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt). The main questions it aims to answer are: * What are the effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt. * Safety of dobutamine infusion in this patient population. Participants will receive increasing doses of dobutamine infusion, and the effects on cardiac output and filling pressures will be assessed simultaneously by echocardiography and right heart catheterization.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. ATTRwt, diagnosis confirmed by genetic testing, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy and/or endomyocardial biopsy. 2. Treated with loop diuretics. 3. New York Heart Association class II-IV. 4. Age ≥ 65 years. 5. Left ventricular ejection fraction (LVEF) \< 50 % and/or SVI assessed by echocardiography \< 35 ml/m2. 6. Thorough oral and written informed consent to participate in the study. Exclusion Criteria: 1. Moderate to severe aortic stenosis (participants with aortic sclerosis will not be excluded). 2. Other significant valvular diseases. 3. Known severe coronary artery diseases: left main stem stenosis or 3-vessel disease, or recent acute myocardial infarction (\< 4 weeks). 4. Contraindications to the use of dobutamine: Known allergy to dobutamine or sulfite, phaeochromocytoma or ventricular tachycardia (VT). 5. End stage renal disease (eGFR of less than 15 mL/min/1,73 m2).
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What it tests

  • Dobutrex
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Where

1 site
Department of Cardiology, Aarhus University Hospital
Aarhus, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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