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Recruiting Phase 1/2

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

NCT06318260 · tracked via the Priya Life Science Denmark tracker
Sponsor
Steen Hvitfeldt Poulsen
Phase
Phase 1/2
Started
2024-04-08
Last updated
2026-06-01

Condition(s) studied

ATTR Amyloidosis Wild Type

Investigational drug(s) / intervention(s)

Dobutrex →

Dobutrex: 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.

Study summary

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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Cardiac output (CO) — Evaluated at every dobutamine dose-level, and at the end of infusion.
    Changes in cardiac output evaluated by the thermodynamic invasive method.

Trial sites (1)

FacilityCityRegionStatus
Department of Cardiology, Aarhus University Hospital Aarhus Denmark Recruiting

More Steen Hvitfeldt Poulsen trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06318260 on ClinicalTrials.gov ↗ ← All trials in Denmark