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

RECRUITINGPhase 1/2Sponsored by Steen Hvitfeldt Poulsen
Actively Recruiting
PhasePhase 1/2
SponsorSteen Hvitfeldt Poulsen
Started2024-04-08
Est. completion2025-09
Eligibility
Age65 Years+
Healthy vol.Accepted

Summary

The goal of this clinical trial is to test the effects of the inotropic drug named dobutamine, in patients with wild-type Transthyretin Amyoid 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 be given increasing dosages of dobutamine infusion, and its effect on cardiac output and filling pressures will be assessed non-invasively by echocardiography, and invasively by right heart catheterization, simultaneously.

Eligibility

Age: 65 Years+Healthy volunteers accepted
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).

Conditions2

ATTR Amyloidosis Wild TypeHeart Disease

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