[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657282":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":31,"studyPopulation":23,"armGroups":32,"interventions":39,"overallOfficials":23,"centralContacts":44,"locations":50,"responsibleParty":64,"collaborators":23,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":23,"enrollmentInfo":78,"targetDuration":23,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":94,"whyStopped":23,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Sao Paulo General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Coronary Flow Reserve","Coronary flow reserve (CFR) will be measured using nitrogen-13 ammonia PET\u002FCT. 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.","Baseline to approximately 6 months",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Change in 6-Minute Walk Distance","Change in distance walked during the 6-minute walk test from baseline to approximately 6 months. A gain of 30 meters or more will be assessed as a clinically relevant improvement.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"Change in Kansas City Cardiomyopathy Questionnaire Score","Change in heart failure-related health status and quality of life measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to approximately 6 months. Higher scores indicate better health status.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":27,"primaryPurpose":28,"observationalModel":23,"timePerspective":23,"maskingInfo":29},"NA","SINGLE_GROUP","Single-arm, open-label pilot study in which all participants receive trimetazidine and are evaluated before and after approximately 6 months of treatment.","TREATMENT",{"masking":30,"maskingDescription":23,"whoMasked":23},"NONE","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.\n\nTrimetazidine 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.\n\nTACT-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.\n\nCoronary physiology will be assessed using quantitative myocardial perfusion imaging with nitrogen-13 ammonia positron emission tomography\u002Fcomputed tomography (PET\u002FCT). 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.\n\nThis 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.",[33],{"label":34,"type":35,"description":36,"interventionNames":37},"Trimetazidine","EXPERIMENTAL","Trimetazidine 35 mg twice daily for 6 months. Participants with an estimated glomerular filtration rate between 30 and 60 mL\u002Fmin\u002F1.73 m² will receive 35 mg once daily.",[38],"Drug: Trimetazidine",[40],{"type":41,"name":34,"description":42,"armGroupLabels":43,"otherNames":23},"DRUG","Participants will receive trimetazidine 35 mg orally twice daily for 6 months. Participants with an estimated glomerular filtration rate between 30 and 60 mL\u002Fmin\u002F1.73 m² will receive 35 mg orally once daily.",[34],[45],{"name":46,"role":47,"phone":48,"phoneExt":23,"email":49},"Rafael Ruas Nastari, MD","CONTACT","+55 11 975111521","rafael_nastari@msn.com",[51],{"facility":52,"status":23,"city":53,"state":53,"zip":23,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Instituto do Coração (InCor), Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo","São Paulo","Brazil","BR",{"type":57,"coordinates":58},"Point",[59,60],-46.63611,-23.5475,{"lat":60,"lon":59},[63],{"name":46,"role":47,"phone":48,"phoneExt":23,"email":49},{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Fábio Fernandes","Collaborating Professor, Department of Cardiopneumology, University of São Paulo Medical School","100657282","phase-2-effect-of-trimetazidine-on-coronary-flow-in-transthyretin-cardiac-amyloidosis-100657282",false,"NCT07836699","Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis","Evaluation of the Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis","TACT-TTR","Inclusion Criteria:\n\n* 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:\n* 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)\n* History of signs or symptoms of heart failure consistent with cardiac amyloidosis\n* Cardiac scintigraphy with technetium-99m pyrophosphate showing grade II or III uptake according to the Perugini scale\n* Age \\>18 years\n* New York Heart Association (NYHA) functional class II, III, or IV\n\nExclusion Criteria:\n\n* Previous adverse reaction, intolerance, or other contraindication to trimetazidine\n* Serum kappa\u002Flambda ratio outside the normal range\n* Use of calcium channel blockers, beta-blockers, or nitrates\n* Obstructive coronary artery disease, defined as \\>50% stenosis in any major epicardial coronary artery, demonstrated by coronary computed tomography angiography\n* Active infection, inflammatory disease, or other systemic condition that may affect myocardial perfusion\n* Contraindication to dipyridamole or PET\u002FCT imaging\n* Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m², calculated using the CKD-EPI equation\n* Pregnancy or postpartum period\n* Presence of diseases other than cardiac amyloidosis that may impair functional capacity or limit ambulation during the 6-minute walk test\n* Other medical conditions or comorbidities that, in the investigator's opinion, may interfere with the course of the study or interpretation of the data\n* Refusal to provide written informed consent","ALL","18 Years",{"count":79,"type":80},20,"ESTIMATED","INTERVENTIONAL",[83],"PHASE2","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.\n\nThe main question this study aims to answer is:\n\nDoes trimetazidine improve the heart's ability to increase its blood flow when more blood is needed?\n\nThe study will also look at whether treatment is linked to changes in walking ability, heart-related blood tests, heart function, and quality of life.\n\nParticipants will:\n\nTake trimetazidine for about 6 months. Have heart blood flow measured with a positron emission tomography\u002Fcomputed tomography (PET\u002FCT) scan before and after treatment.\n\nHave heart ultrasound examinations and blood tests. Complete a 6-minute walk test and a questionnaire about their symptoms and quality of life.",[86],"Transthyretin Cardiac Amyloidosis",[86,88,34,89,90,91,92,93],"ATTR-CM","Coronary Flow Reserve","Coronary Microvascular Dysfunction","Myocardial Blood Flow","Myocardial Perfusion","Nitrogen-13 Ammonia PET\u002FCT","NOT_YET_RECRUITING","2026-09-17",{"date":97,"type":98},"2026-09-23","ACTUAL",{"date":100,"type":80},"2026-09-01",{"date":102,"type":80},"2027-09-01",{"name":66,"class":6},1]