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

Sponsor

Steen Hvitfeldt Poulsen (Other)

Overall Status

Recruiting

CT.gov ID

NCT05633563

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Transthyretin Amyloid Cardiopathy Mitochondrial Pathology	Drug: Trimetazidine Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Oct 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change: pulmonary capillary wedge pressure (PCWP) [Four weeks of treatment]
We hypothesize a change in PCWP of 5 mmHg between the active drug and placebo using right heart catheterization.

Secondary Outcome Measures

Change: cardiac index (CI) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital, Department of Cardiology	Aarhus N	Danmark	Denmark	8200

Sponsors and Collaborators

Steen Hvitfeldt Poulsen

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Steen Hvitfeldt Poulsen, Professor, PhD, DMSci, Aarhus University Hospital Skejby

ClinicalTrials.gov Identifier:

NCT05633563

Other Study ID Numbers:

72864

First Posted:

Dec 1, 2022

Last Update Posted:

Jan 27, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Amyloidosis

Trimetazidine

Study Results

No Results Posted as of Jan 27, 2023