Left Atrial Strain and Supraventricular Arrhythmia Burden in Cardiac Light Chain Amyloidosis Following Chemotherapy

Study Overview
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Brief Summary
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The purpose of this study to assess the longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapeutic strategies in cardiac light chain amyloidosis.

Detailed Description
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Light chain (AL) amyloidosis is a disease characterized by localized or systemic accumulation of amyloid fibrils in tissues caused by abnormal folding of light chain immunoglobulins and affecting organ functions. Due to the accumulation of abnormal folding immunoglobulins in the cardiac conduction system, arrhythmia susceptibility has been reported to increase significantly. Atrioventricular blocks and supraventricular arrhythmia are mainly detected among the most common arrhythmia. While these developing supraventricular arrhythmias and atrioventricular blocks in non-amyloidosis diseases result in increased mortality and morbidity, there is insufficient data on cardiac AL amyloidosis treated with chemotherapy. For this reason, this study was planned, and the purpose of this study is to assess the longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapeutic strategies in cardiac light chain amyloidosis. After being informed about the study, it is planned to recruit and follow up AL-Amyloidosis patients with cardiac involvement who are currently receiving/planned chemotherapy followed by hematology or who are planned for bone marrow transplantation within one year after obtaining written consent from the patients.

Official Title
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Longitudinal Changes in Left Atrial Strain and Supraventricular Arrhythmia Burden in Cardiac Light Chain Amyloidosis Patients Following Chemotherapy

Conditions
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Supraventricular Arrhythmia, Left Atrial Abnormality, Amyloid Cardiomyopathy, Congestive Heart Failure

Intervention / Treatment
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* Diagnostic Test: Left Atrial Strain Imaging
* Diagnostic Test: Electrocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 years old Patients who give the informed consent Patients with cardiac primary light chain amyloidosis or due to multiple myeloma who are newly diagnosed, currently receiving chemotherapeutic treatment, or are scheduled for bone marrow transplantation Exclusion Criteria: A history of myocardial infarction, coronary artery disease, percutaneous coronary intervention and revascularization < 18 years old A history of severe aortic and mitral valve disease Patients who do not give the informed consent A history of severe hypertension (SBP>180 mmHg or DBP ≥110 mmHg or the need to use three or more antihypertensive agents) Stable coronary artery patients with ischemia data in stress tests (exertion test, myocardial perfusion scintigraphy) Presence of non-amyloidosis, systemic, inflammatory or autoimmune disease Patients whose cardiac imaging is not interpretable Patients whose ECG is not interpretable

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Light Chain Cardiac Amyloidosis<br>Participants with light chain cardiac amyloidosis actively receiving chemotherapy or undergoing autologous bone marrow transplant | Diagnostic Test: Left Atrial Strain Imaging<br>* Two-dimensional, color Doppler, spectral Doppler recordings will be taken from parasternal, apical, subcostal, and modified sections using a Philips Epiq CVx echocardiography device and X5-1 probe. Conventional parameters, additional parameters, and strain analyzes will be performed with speckle tracking echocardiography from these recordings.<br>* Other names: Philips X5-1 3D Echocardiography Probe;Diagnostic Test: Electrocardiography<br>* Electrocardiography will be taken at baseline and the follow-up periods<br>* Other names: Mindray BeneHeart R12 ECG system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prognostic significance of longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapy in cardiac light chain amyloidosis | In this study, the effects of treatment strategies on left atrial strain imaging and supraventricular arrhythmia burden and its relationship with mortality and morbidity will be investigated in patients with AL-amyloidosis, who are still under treatment, and newly diagnosed with AL-amyloidosis. | Baseline, and 1st, 3rd, 6th, 12th Month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effects of treatment strategies on arrhythmia burden | By obtaining the serial ECG records, arrhythmia burden will be recorded/ | Baseline, and 1st, 3rd, 6th, 12th Month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid Cardiomyopathy, Left atrial strain, Supraventricular Arrhythmia, Heart failure, cardiac amyloidosis, Arrhythmia, Strain Imaging