ClinicalTrials.gov record NCT07836699

Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 28, 2026

Evaluation of the Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
Age18 years old and older
SexAll
LocationBrazil
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This Phase 2, single-arm pilot study tests trimetazidine in adults with transthyretin cardiac amyloidosis (ATTR-CM). Participants will take trimetazidine for about 6 months and will have heart blood flow measured with nitrogen-13 ammonia PET/CT before and after treatment. The study also collects heart ultrasound, blood tests, a 6-minute walk test, and a quality-of-life questionnaire.

What it is studying. The study tests whether trimetazidine changes coronary microvascular function by measuring change in coronary flow reserve (the heart's ability to increase blood flow) using nitrogen-13 ammonia PET/CT. It will also assess changes in 6-minute walk distance, NT-proBNP blood levels, heart function measures, and heart‑related quality of life.

What the researchers hope to learn. To gather preliminary evidence on whether trimetazidine affects coronary microvascular function and coronary flow reserve in ATTR-CM and to generate data to inform future controlled trials.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • Trimetazidine

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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 criteria

  • Previous adverse reaction, intolerance, or other contraindication to trimetazidine
  • Serum kappa/lambda ratio outside the normal range
  • Use of calcium channel blockers, beta-blockers, or nitrates
  • 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
  • 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
  • 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
  • Refusal to provide written informed consent

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take trimetazidine orally for about 6 months (typically 35 mg twice daily; 35 mg once daily for those with estimated glomerular filtration rate between 30 and 60 mL/min/1.73 m²). You will have a nitrogen-13 ammonia PET/CT scan before treatment and again at about 6 months to measure myocardial blood flow at rest and during pharmacologic stress for calculation of coronary flow reserve. You will also have heart ultrasound examinations, blood tests, a 6-minute walk test, and questionnaires about symptoms and quality of life during follow-up. Assessments are done at baseline and after the treatment period to compare changes over time.

How the study is structured. Open-label, single-group Phase 2 pilot study at one center enrolling about 20 adults with ATTR-CM. Participants receive oral trimetazidine (35 mg twice daily; 35 mg once daily for participants with reduced kidney function as specified) for approximately 6 months. Coronary blood flow is measured with nitrogen-13 ammonia PET/CT at baseline and after treatment; participants also have heart ultrasound, blood tests, a 6-minute walk test, and complete a heart‑failure quality-of-life questionnaire. The study is not masked and has no comparison/placebo group.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in Brazil. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on wild-type ATTR amyloidosis

Clinical trials121 trials listed for wild-type ATTR amyloidosisEvery trial the registry lists for wild-type ATTR amyloidosis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in wild-type ATTR amyloidosis researchLatest monthly update: September 2026. Includes: Frailty and support needs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Sep 1, 2026 (estimated)
Primary completion
Aug 1, 2027 (estimated)
Study completion
Sep 1, 2027 (estimated)
Target enrollment
20 participants (estimated)
Last updated on registry
Sep 23, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Fábio Fernandes

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo · Brazil

Terms used on this page · explanations by MedicalUpdates.ai

positron emission tomography
A scan in which a small amount of a radioactive tracer is injected so that activity in tissues can be seen. Often combined with a CT or MRI scan.
computed tomography
An X-ray scan that builds detailed cross-section images of the body. 'High-resolution' CT (HRCT) is used to look closely at the lungs.
6-minute walk test
A test of how far a person can walk on a flat surface in six minutes. It is used to measure stamina and to track change over time.
biopsy
Removal of a small piece of tissue so it can be examined under a microscope. 'Biopsy-proven' or 'histologically confirmed' means the diagnosis was confirmed by examining tissue under a microscope.
echocardiography
An ultrasound scan of the heart. A transesophageal echocardiogram is done through a probe passed into the food pipe for a closer view.
magnetic resonance imaging
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
contraindication
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Estimated glomerular filtration rate
A blood-test estimate of how well the kidneys are filtering. Lower numbers mean reduced kidney function; many studies set a minimum value.
written informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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