A Phase 2 interventional study of Trimetazidine in Transthyretin Cardiac Amyloidosis, sponsored by Fábio Fernandes. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Fábio Fernandes · Phase 2, Interventional, and Treatment
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.
Transthyretin cardiac amyloidosis (ATTR-CM) is characterized by the deposition of transthyretin amyloid fibrils within the myocardium. In addition to myocardial infiltration, amyloid deposition may involve intramyocardial vessels and contribute to coronary microvascular dysfunction. This may lead to impaired myocardial perfusion and reduced coronary flow reserve even in the absence of significant obstructive epicardial coronary artery disease.
Trimetazidine is a metabolic modulator that shifts myocardial energy metabolism from fatty acid oxidation toward glucose oxidation. This metabolic effect may improve myocardial energy efficiency and reduce oxygen requirements for adenosine triphosphate production. These properties provide the rationale for investigating whether trimetazidine may improve coronary microvascular function in people with ATTR-CM.
TACT-TTR is a prospective, open-label, single-center, single-arm pilot clinical trial conducted at the Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP). The study will enroll 20 participants with ATTR-CM who will receive trimetazidine and undergo approximately 6 months of follow-up.
Coronary physiology will be assessed using quantitative myocardial perfusion imaging with nitrogen-13 ammonia positron emission tomography/computed tomography (PET/CT). Myocardial blood flow will be measured at rest and during pharmacologic stress, allowing calculation of coronary flow reserve as the ratio of stress myocardial blood flow to resting myocardial blood flow. Participants will undergo assessments before and after the treatment period to investigate changes in coronary microvascular function. Additional clinical, imaging, laboratory, functional, and health-related quality-of-life assessments will be performed during follow-up.
This exploratory pilot study is intended to provide preliminary evidence on the potential role of trimetazidine as an adjunctive metabolic therapy targeting coronary microvascular dysfunction in ATTR-CM and to generate data that may support the design of future controlled clinical trials.
290 studies on the registry are indexed under Amyloidosis; 92 are open to participants now.
This study's planned enrollment of 20 is below the median of 46 across 189 interventional studies indexed under Amyloidosis.
Browse Amyloidosis studies →Fábio Fernandes is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Trimetazidine 35 mg twice daily for 6 months. Participants with an estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m² will receive 35 mg once daily.
Drug: Trimetazidine
Participants will receive trimetazidine 35 mg orally twice daily for 6 months. Participants with an estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m² will receive 35 mg orally once daily.
Change in Coronary Flow Reserve
Coronary flow reserve (CFR) will be measured using nitrogen-13 ammonia PET/CT. CFR is calculated as the ratio of myocardial blood flow during pharmacologic stress to myocardial blood flow at rest. The outcome will assess the change in CFR from baseline to the end of trimetazidine treatment.
Time frame: Baseline to approximately 6 months
Change in 6-Minute Walk Distance
Health-related quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status and fewer heart failure-related symptoms and limitations. The change in KCCQ score from baseline to approximately 6 months will be assessed.
Time frame: Baseline to approximately 6 months
Change in NT-proBNP
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration from baseline to approximately 6 months. The study will assess whether NT-proBNP decreases by 30% or more from baseline.
Time frame: Baseline to approximately 6 months
Change in Kansas City Cardiomyopathy Questionnaire Score
Health-related quality of life will be assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ). Scores range from 0 to 100, with higher scores indicating better health status and fewer heart failure-related symptoms and limitations. The change in KCCQ score from baseline to approximately 6 months will be assessed.
Time frame: Baseline to approximately 6 months
Plan to share: No — Individual participant data (IPD) are not planned to be shared because the current study protocol does not include a formal plan for sharing de-identified participant-level data with external researchers. Study results will be disseminated through scientific presentations and publication.
Start is estimated for Jan 2027; primary completion for Aug 2027, 7 months later.
Of 24 phase 2 interventional studies under Amyloidosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 64. This study's planned 7 months is below that.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Jan 2027, on Oct 23, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Trimetazidine