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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorSteen Hvitfeldt Poulsen

About this trial

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.

Eligibility criteria

Qualifiers

ATTRwt, diagnosis confirmed by genetic testing, 99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid (DPD) scintigraphy and/or endomyocardial biopsy.

Treated with loop diuretics.

New York Heart Association class II-IV.

Age ≥ 65 years.

Disqualifiers

Moderate to severe aortic stenosis (participants with aortic sclerosis will not be excluded).

Other significant valvular diseases.

Known severe coronary artery diseases: left main stem stenosis or 3-vessel disease, or recent acute myocardial infarction (< 4 weeks).

Contraindications to the use of dobutamine: Known allergy to dobutamine or sulfite, phaeochromocytoma or ventricular tachycardia (VT).

Trial design

Treatments tested in this trial

  • Dobutrex

Treatment groups

15 Participants
are divided into 1 treatment group

Sponsors and collaborators

Steen Hvitfeldt Poulsen

Lead sponsor

Aarhus University Hospital Skejby

Sponsor institution