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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05633563

Acronym

CACTuS - TMZ

Enrollment

Registered

2022-12-01

Start date

2021-10-01

Completion date

2023-06-01

Last updated

2024-04-25

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

Conditions

Mitochondrial Pathology, Transthyretin Amyloid Cardiopathy

Brief summary

Wild-type transthyretin cardiac amyloidosis (ATTRwt) is a deposition disorder in which one of the proteins of the body misfolds and accumulates at various places in the body, including the heart, leading to both mechanical and cellular damage. The gradual development of the disease will ultimately lead to heart failure and death The protein which deposits in the heart of patients, damages both the heart mechanically as the myocardium becomes rigid and hypertrophic over time but also at the cellular level. Cell damage can be observed by elevated blood tests for cell damage (Troponin) and during exercise tests that show patients' hearts burning oxygen inefficiently when exposed to physical stress compared with the hearts of healthy individuals . No one has, however, intimately studied this cellular damage. Vastarel® (Trimetazidine, TMZ) is an already known drug for the treatment of chest pain. The mechanism of action indicates that it may have an effect on patients with cardiac amyloidosis. The study aims to investigate the effects of TMZ on the mitochondrial function, myocardial performance, and invasive hemodynamics in patients with ATTRwt with a randomized, double-blinded, crossover-trial.

Interventions

DRUGTrimetazidine

Oral intake of capsules

DRUGPlacebo

Oral intake of capsules

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

Inclusion criteria

* Wild-type transthyretin cardiac amyloidosis * NAC stage I * NYHA class of I or II * Informed consent

Exclusion criteria

* Other, similar diagnoses * Hereditary transthyretin cardiac amyloidosis * Light chain amyloidosis * Morbus Waldenstrøm * Myelomatosis * Medical treatment with loop diuretics in standard doses (40 mgx1 daily) * Contraindications to trimetazidine * Significant comorbidity assessed by the investigators * Unable to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
Change: pulmonary capillary wedge pressure (PCWP)	Four weeks of treatment	We hypothesize a change in PCWP of 5 mmHg between the active drug and placebo using right heart catheterization.

Secondary

Measure	Time frame	Description
Change: cardiac index (CI)	Four weeks of treatment	We hypothesize a change in CI of 0.5 L/min between the active drug and placebo using right heart catheterization.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026