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

ConditionATTR Amyloidosis Wild Type

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Dobutrex
Drug
Dobutamine (Dobutrex®) infusion. will be performed with a stepwise dobutamine dosage increase every 5 minutes (2,3,5,10,20 ug/kg/min). Dobutamine dosage will only be increased to 40 ug/kg/min in participants with ongoing beta-blocker treatment to ensure an appropriate dobutamine response. As dobutamine and its metabolites are excreted renally, the dose will be reduced to max 10 ug/kg/min in participants with eGFR below 30 mL/min/1,73 m2. Echocardiography, blood pressure, heart rate, and invasive pressure and flow measurements will be obtained before the infusion starts, at each infusion stage, and during the recovery period after the infusion is stopped.

Treatment groups

15 Participants

are divided into 1 treatment group

Group A: ATTRwtExperimental treatment 1 intervention

Trial outcomes