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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-11

Study Completion Date

2023-10-30

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.

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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.

Conditions

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Amyloid Cardiomyopathy Congestive Heart Failure Chemotherapy Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Light Chain Cardiac Amyloidosis

Participants with light chain cardiac amyloidosis actively receiving chemotherapy or undergoing autologous bone marrow transplant

Left and Right Ventricular Global Strain Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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Left and Right Ventricular Global Strain Imaging

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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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TomTec AutoStrain Suite Software Philips Epiq CVx Echocardiography System Philips X5-1 3D Echocardiography Probe

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No