Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-25 @ 2:02 AM
NCT ID:
NCT06318260
Eligibility 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06318260
Study Brief:
Protocol Section:
NCT06318260