Effect of Trimetazidine on Coronary Flow in Transthyretin Cardiac Amyloidosis
ConditionTransthyretin Cardiac Amyloidosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFábio Fernandes
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Trimetazidine
DrugParticipants 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: TrimetazidineExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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.
Time frame
Baseline to approximately 6 months2
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 months3
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.
Time frame
Baseline to approximately 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Fábio Fernandes
Lead sponsor
University of Sao Paulo General Hospital
Sponsor institution
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: