Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis

Study Overview
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Brief Summary
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The purpose of this study to assess the longitudinal changes in left and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.

Detailed Description
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Light chain 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. In the treatment, chemotherapeutic agents are used that prevent the clonal proliferation of plasma cells in the bone marrow. Although the hematological response is standardized in evaluating the treatment response, there is no adequately effective method for assessing cardiac response. Despite the use of various scores, imaging-based systems continue to be developed to increase the sensitivity of these methods. 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 1 year after obtaining written consent from the patients.

Official Title
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Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis: Prognostic Significance

Conditions
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Amyloid Cardiomyopathy, Congestive Heart Failure, Chemotherapy Effect

Intervention / Treatment
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* Diagnostic Test: Left and Right Ventricular Global Strain Imaging


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, PCI 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

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 and Right Ventricular Global Strain Imaging<br>* Two-dimensional, color Doppler, spectral Doppler, and 3D digital echocardiographic image 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;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis | In this study, the effects of treatment strategies on left and right ventricular global and regional strain 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. | Change from Baseline left and right ventricular global strain at 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging | Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging was planned as a secondary objective. | 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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Cardiac amyloidosis, Cardiomyopathy, Heart failure, Chemotherapy, Echocardiography, Strain imaging