Effects of dobutamine on heart function in patients with a specific type of heart disease
Haemodynamic Effects of Dobutamine in Patients With Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt)
This study is testing whether dobutamine can help improve heart function in older patients with a specific type of heart disease called wild-type Transthyretin Amyloid Cardiomyopathy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Aarhus University Hospital Skejby Academic / other |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06318260 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the hemodynamic effects of dobutamine infusion in patients with wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt). Participants aged 65 and older with symptomatic ATTRwt will receive increasing dosages of dobutamine, and its impact on cardiac output and filling pressures will be assessed using both non-invasive echocardiography and invasive right heart catheterization. The study aims to determine the safety and efficacy of dobutamine in improving heart function in this patient population.
Who should consider this trial
Good fit: Ideal candidates are symptomatic patients aged 65 and older with ATTRwt and reduced left ventricular ejection fraction.
Not a fit: Patients with significant valvular diseases, severe coronary artery diseases, or contraindications to dobutamine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with symptomatic ATTRwt by enhancing heart function.
How similar studies have performed: While the use of dobutamine in heart failure has been studied, this specific application in ATTRwt is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Aarhus
- Department of Cardiology, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
Study contacts
- Study coordinator: Ali Hussein Jaber Mejren, MD
- Email: alimej@clin.au.dk
- Phone: 0045 91 65 18 48
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.