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NCT07836699Not yet recruitingPhase 2

Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis

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

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
First submitted
17 Sept 2026
Start date
1 Jan 2027
Primary completion date
1 Aug 2027
Lead sponsor
Fábio Fernandes
Diseases
Amyloidosis
NCT number
NCT07836699

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 20
  • From 1 Jan 2027 to the primary completion date, 1 Aug 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous adverse reaction, intolerance, or other contraindication to trimetazidine

Other illness

  • 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

Lab values

  • Serum kappa/lambda ratio outside the normal range
  • Use of calcium channel blockers, beta-blockers, or nitrates

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.