Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
Summary
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.
Timeline
- Start
- 2026-09-01
- Primary completion
- 2027-08-01
- Completion
- 2027-09-01
Publications
- Background Fernandes F, Luzuriaga GDCJ, da Fonseca GWP, Correia EB, Carvalho AAS, Macedo AVS, Coelho-Filho OR, Scheinberg P, Antunes MO, Schwartzmann PV, Mangini S, Marques W, Simoes MV. Clinical and genetic profiles of patients with hereditary and wild-type transthyretin amyloidosis: the Transthyretin Cardiac Amyloidosis Registry in the state of Sao Paulo, Brazil (REACT-SP). Orphanet J Rare Dis. 2024 Jul 20;19(1):273. doi: 10.1186/s13023-024-03281-z.
- Background Gao D, Ning N, Niu X, Hao G, Meng Z. Trimetazidine: a meta-analysis of randomised controlled trials in heart failure. Heart. 2011 Feb;97(4):278-86. doi: 10.1136/hrt.2010.208751. Epub 2010 Dec 5.
- Background Dorbala S, Vangala D, Bruyere J Jr, Quarta C, Kruger J, Padera R, Foster C, Hanley M, Di Carli MF, Falk R. Coronary microvascular dysfunction is related to abnormalities in myocardial structure and function in cardiac amyloidosis. JACC Heart Fail. 2014 Aug;2(4):358-67. doi: 10.1016/j.jchf.2014.03.009. Epub 2014 Jul 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Trimetazidine | Small molecule | 35 mg | Oral |
Indications
No indication recorded.