The Effect of Trimetazidine on Cardiac Function in Patients with Cardiac Amyloidosis.

The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed with Wild-Type Transthyretin Cardiac Amyloidosis.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001617-21-DK

Enrollment

Registered

2020-04-14

Start date

2020-08-27

Completion date

Unknown

Last updated

2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wild-Type Transthyretin Cardiac Amyloidosis

Interventions

Trade Name: Vastarel Pharmaceutical Form: INN or Proposed INN: TRIMETAZIDINE CAS Number: 5011-34-7 Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 60 years for men. Age = 70 years for women - TC99-DPD-scintigraphy positive for cardiac involvement (Perugini II-III) - Negative serum immunofixation - Normal Kappa/Lambda ratio - Gillmore stage I (NT-proBNP = 3000 ng/L, eGFR = 45 mL/min) - NYHA-class I-IIa - Informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36

Exclusion criteria

Exclusion criteria: - Already known, similar diagnosis o Hereditary Transthyretin Cardiac Amyloidosis (ATTRh) o Light Chain Amyloidosis (AL Amyloidosis) o Monoclonal Gammopathy of Unspecified Significance (MGUS) o Myelomatosis o Mb. Waldenstrøm - Medical treatment with loop diuretics - Contraindications to TMZ (Allergic reaction, Parkinson’s Disease, Tremor, Restless Leg Syndrome, eGFR < 30 mL/min) - Contraindications to TC99-DPD-skintigraphy (allergic reaction to contrast) - Significant co-morbidity assessed by the investigator - Patients for whom informed consent cannot be collected (mental illness, dementia)

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of this study is: 1) to characterize the oxidative capacity of myocardial mitochondria as well as to investigate the treatment effect of Trimetazidine (TMZ) in patients with stage 1 cardiac amyloidosis in a double-blind, placebo-controlled cross-over study; 2) to examine the effect of TMZ at rest and during exercise on systolic and diastolic function measured by right heart catheterization (RHC) and advanced echocardiography; 3) to investigate and characterize the morphology of myocardial myocytes and mitochondria by electron microscopy; 4) to compare the oxidative capacity, morphology, and myocardial function of mitochondria in patients with early-stage asymptomatic disease versus patients with more advanced symptomatic disease. ;Secondary Objective: Not applicable;Primary end point(s): The primary end point is cardiac index measured by RHC. ;Timepoint(s) of evaluation of this end point: At study completion.	—

Measure

Time frame

Main Objective: The purpose of this study is: 1) to characterize the oxidative capacity of myocardial mitochondria as well as to investigate the treatment effect of Trimetazidine (TMZ) in patients with stage 1 cardiac amyloidosis in a double-blind, placebo-controlled cross-over study; 2) to examine the effect of TMZ at rest and during exercise on systolic and diastolic function measured by right heart catheterization (RHC) and advanced echocardiography; 3) to investigate and characterize the morphology of myocardial myocytes and mitochondria by electron microscopy; 4) to compare the oxidative capacity, morphology, and myocardial function of mitochondria in patients with early-stage asymptomatic disease versus patients with more advanced symptomatic disease. ;Secondary Objective: Not applicable;Primary end point(s): The primary end point is cardiac index measured by RHC. ;Timepoint(s) of evaluation of this end point: At study completion.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary end points are mitochondrial respiration measured by high resolution respirometry, left ventricular global longitudinal strain measured by transthoracic echocardiography, and walking distance on the 6-minute walk test.;Timepoint(s) of evaluation of this end point: At study completion.	—

Countries

Denmark

Contacts

Public ContactDepartment of Cardiology

Aarhus University Hospital

berlad@rm.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026