NCT06318260RecruitingPhase 1
Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)
Steen Hvitfeldt Poulsen2 sites in 1 country15 target enrollmentStarted: April 8, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Cardiac output
Study Overview
Brief 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.
Detailed Description
AIMS
- To investigate the hemodynamic effects of increasing dosages of dobutamine infusion on cardiac output and filling pressures in patients with symptomatic ATTRwt, assessed simultaneously by right heart catheterization (RHC) and echocardiography.
- To assess the safety of dobutamine infusion in ATTRwt patients.
HYPOTHESIS
- Dobutamine infusion can increase myocardial contractility significantly in patients with symptomatic ATTRwt
- Dobutamin infusion can cause a significant decrease in the left ventricular filling pressure, as expressed by the pulmonary artery wedge pressure (PAWP) and/or mean pulmonary artery pressure (mPAP)
- Dobutamine is well-tolerated and safe to use in symptomatic ATTRwt patients.
MATERIALS AND METHODS
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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/m
- •Thorough oral and written informed consent to participate in the study.
Exclusion Criteria
- •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).
- •End stage renal disease (eGFR of less than 15 mL/min/1,73 m2).
Arms & Interventions
ATTRwt
Experimental
Dobutamine (Dobutrex®) infusion.
Intervention: Dobutrex (Drug)
Outcomes
Primary Outcomes
Cardiac output
Time Frame: Evaluated at every dobutamine dose-level, and at the end of infusion.
Mean cardiac output increase by 10%, evaluated by the thermodynamic invasive methods.
Secondary Outcomes
- Reduction in mean PAWP and/or mPAP by 10 %.(Evaluated at every dobutamine dose-level, and at the end of infusion.)
- Increase in LVEF and LV-global longitudinal strain (LV-GLS) of absolute 10 %.(Evaluated at every dobutamine dose-level, and at the end of infusion.)
- Correlation between echo- and invasive measured SVI, and CO.(Evaluated at every dobutamine dose-level, and at the end of infusion.)
- Increase in invasively measured SVI by ≥ 20%.(Evaluated at every dobutamine dose-level, and at the end of infusion.)
- Rate of complications (i.e. Systolic blood pressure drop < 90 mmHg, arrhythmias)/symptomatic side effects.(Evaluated at every dobutamine dose-level, at the end of infusion, and during the 2 hours recovery period.)
Investigators
Steen Hvitfeldt Poulsen
Professor, DMSc.
Aarhus University Hospital Skejby
Study Sites (2)
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