Back to resultsThe Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis (CACTuS - TMZ)
Primary Purpose
Transthyretin Amyloid Cardiopathy, Mitochondrial Pathology
Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Trimetazidine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Transthyretin Amyloid Cardiopathy
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
Sites / Locations
- Aarhus University Hospital, Department of CardiologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Drug
Placebo
Arm Description
Study participants receiving Trimetazidine
Study participants receiving placebo (calcium)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05633563
Brief Title
The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steen Hvitfeldt Poulsen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transthyretin Amyloid Cardiopathy, Mitochondrial Pathology
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Drug
Arm Type
Active Comparator
Arm Description
Study participants receiving Trimetazidine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Study participants receiving placebo (calcium)
Intervention Type
Drug
Intervention Name(s)
Trimetazidine
Intervention Description
Oral intake of capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral intake of capsules
Primary Outcome Measure Information:
Title
Change: pulmonary capillary wedge pressure (PCWP)
Description
We hypothesize a change in PCWP of 5 mmHg between the active drug and placebo using right heart catheterization.
Time Frame
Four weeks of treatment
Secondary Outcome Measure Information:
Title
Change: cardiac index (CI)
Description
We hypothesize a change in CI of 0.5 L/min between the active drug and placebo using right heart catheterization.
Time Frame
Four weeks of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bertil T Ladefoged, MD
Phone
+4540927245
Email
berlad@rm.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Steen H Poulsen, MD
Phone
+4530922309
Email
hvitfeldt@indbakke.dk
Facility Information:
Facility Name
Aarhus University Hospital, Department of Cardiology
City
Aarhus N
State/Province
Danmark
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertil Ladefoged, MD
Phone
+4540927245
Email
berlad@rm.dk
First Name & Middle Initial & Last Name & Degree
Steen Hvitfeldt Poulsen, DMSc
Phone
+4530922309
Email
steepoul@rm.dk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Effect of Trimetazidine on Mitochondrial Function, Myocardial Performance, and Invasive Hemodynamics in Patients Diagnosed With Wild-Type Transthyretin Cardiac Amyloidosis
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