Tests trimetazidine for heart blood flow in transthyretin cardiac amyloidosis
Tests whether trimetazidine improves heart blood flow in adults with transthyretin cardiac amyloidosis.
Plain-language title generated from the registry record
Registry title: Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
Where in Brazil
- Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São PauloSão Paulo, BrazilNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fábio Fernandes
- Trial code
- NCT07836699
- Record updated
- 23 October 2026
- Original description
The goal of this clinical trial is to learn if trimetazidine can improve blood flow in the heart in adults with transthyretin cardiac amyloidosis (ATTR-CM). ATTR-CM is a condition in which an abnormal protein builds up in the heart and can make it harder for the heart to work normally.Read full original descriptionShow less
Evaluation of the Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
The goal of this clinical trial is to learn if trimetazidine can improve blood flow in the heart in adults with transthyretin cardiac amyloidosis (ATTR-CM). ATTR-CM is a condition in which an abnormal protein builds up in the heart and can make it harder for the heart to work normally.
The main question this study aims to answer is:
Does trimetazidine improve the heart's ability to increase its blood flow when more blood is needed?
The study will also look at whether treatment is linked to changes in walking ability, heart-related blood tests, heart function, and quality of life.
Participants will:
Take trimetazidine for about 6 months. Have heart blood flow measured with a positron emission tomography/computed tomography (PET/CT) scan before and after treatment.
Have heart ultrasound examinations and blood tests. Complete a 6-minute walk test and a questionnaire about their symptoms and quality of life.
Inclusion: Diagnosis of transthyretin cardiac amyloidosis confirmed by all protocol-specified diagnostic criteria or by Congo red-positive tissue biopsy with cardiac involvement. The diagnostic criteria listed in the current protocol include:; Interventricular septal thickness >12 mm on echocardiography or cardiac magnetic resonance imaging, in the absence of other causes of hypertrophy (e.g., hypertension or aortic stenosis); History of signs or symptoms of heart failure consistent with cardiac amyloidosis; Cardiac scintigraphy with technetium-99m pyrophosphate showing grade II or III uptake according to the Perugini scale; Age >18 years; New York Heart Association (NYHA) functional class II, III, or IV.
Exclusion: Previous adverse reaction, intolerance, or other contraindication to trimetazidine; Obstructive coronary artery disease, defined as >50% stenosis in any major epicardial coronary artery, demonstrated by coronary computed tomography angiography; Active infection, inflammatory disease, or other systemic condition that may affect myocardial perfusion; Presence of diseases other than cardiac amyloidosis that may impair functional capacity or limit ambulation during the 6-minute walk test; Other medical conditions or comorbidities that, in the investigator's opinion, may interfere with the course of the study or interpretation of the data; Serum kappa/lambda ratio outside the normal range; Use of calcium channel blockers, beta-blockers, or nitrates; Contraindication to dipyridamole or PET/CT imaging; Estimated glomerular filtration rate <30 mL/min/1.73 m², calculated using the CKD-EPI equation; Pregnancy or postpartum period; Refusal to provide written informed consent.