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

April 24, 2024 updated by: Steen Hvitfeldt Poulsen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bertil T Ladefoged, MD
  • Phone Number: +4540927245
  • Email: berlad@rm.dk

Study Contact Backup

Study Locations

  • Denmark
    • Danmark
      • Aarhus N, Danmark, Denmark, 8200
        • Aarhus University Hospital, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active Drug
Study participants receiving Trimetazidine
Drug: Trimetazidine
Oral intake of capsules
Placebo Comparator: Placebo
Study participants receiving placebo (calcium)
Drug: Placebo
Oral intake of capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Four weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steen Hvitfeldt Poulsen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

October 15, 2021

First Submitted That Met QC Criteria

November 21, 2022

First Posted (Actual)

December 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 72864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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