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OpenTrials
Completed

NCT Number: NCT05633563

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

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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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aarhus University Hospital, Department of Cardiology

Aarhus N, Danmark, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trimetazidine

Drug

Oral intake of capsules

Placebo

Drug

Oral intake of capsules

Primary outcomes

  1. Change: pulmonary capillary wedge pressure (PCWP)

    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.

Secondary outcomes

  1. Change: cardiac index (CI)

    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.

Sponsors and collaborators

Lead sponsor

Steen Hvitfeldt Poulsen

Other

Registry information

Acronym: CACTuS - TMZ

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Dec 1, 2022
Registry last updated
Apr 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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