Aarhus University Hospital, Department of Cardiology
Aarhus N, Danmark, 8200, Denmark
NCT Number: NCT05633563
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.
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Notify Me60 year and older
All sexes
Interventional
Phase 4
Aarhus N, Danmark, 8200, Denmark
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral intake of capsules
Oral intake of capsules
Time frame: Four weeks of treatment
We hypothesize a change in PCWP of 5 mmHg between the active drug and placebo using right heart catheterization.
Time frame: 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.
Steen Hvitfeldt Poulsen
Other
Acronym: CACTuS - TMZ
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