NCT06318260RecruitingPhase 1/2
Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)
Source: ClinicalTrials.gov · Last updated 1 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 12 Mar 2024
- Start date
- 8 Apr 2024
- Primary completion date
- Jul 2026
- Lead sponsor
- Steen Hvitfeldt Poulsen
- Diseases
- Amyloidosis
- NCT number
- NCT06318260
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 15
- From 8 Apr 2024 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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).
Lab values
- End stage renal disease (eGFR of less than 15 mL/min/1,73 m2).
Other
- Moderate to severe aortic stenosis (participants with aortic sclerosis will not be excluded).
Who the study is looking for
- 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.
- Left ventricular ejection fraction (LVEF) \< 50 % and/or SVI assessed by echocardiography \< 35 ml/m2.
- Thorough oral and written informed consent to participate in the study.
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Cardiology Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.