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

Mitochondrial Pathology Clinical Trial

— CACTuS - TMZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05633563
• Other study ID #: 72864
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2024
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyloidosis
• Mitochondrial Pathology
• Transthyretin Amyloid Cardiopathy

Intervention

Drug:
• Trimetazidine
Oral intake of capsules
• Placebo
Oral intake of capsules

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital, Department of Cardiology	Aarhus N	Danmark

Sponsors (1)

Lead Sponsor	Collaborator
Steen Hvitfeldt Poulsen

Country where clinical trial is conducted

Denmark, 

Outcome

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