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

Istanbul University - Cerrahpasa (IUC)

Status

Active, not recruiting

Conditions

Chemotherapy Effect

Amyloid Cardiomyopathy

Congestive Heart Failure

Treatments

Diagnostic Test: Left and Right Ventricular Global Strain Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT05452850

2021-53809

Details and patient eligibility

About

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.

Full description

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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