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

NCT ID: NCT05633563

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2023-06-01

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.

Conditions

Transthyretin Amyloid Cardiopathy; Mitochondrial Pathology

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active Drug

Study participants receiving Trimetazidine

Group Type: ACTIVE_COMPARATOR

Trimetazidine

Intervention Type: DRUG

Oral intake of capsules

Placebo

Study participants receiving placebo (calcium)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral intake of capsules

Interventions

Trimetazidine

Oral intake of capsules

Intervention Type: DRUG

Placebo

Oral intake of capsules

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steen Hvitfeldt Poulsen

OTHER

Sponsor Role: lead

Responsible Party

Steen Hvitfeldt Poulsen

Professor, PhD, DMSci

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Aarhus University Hospital, Department of Cardiology

Aarhus N, Danmark, Denmark

Countries

Denmark

Other Identifiers

72864

Identifier Type: -

Identifier Source: org_study_id