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

Active, not recruiting

• Conditions: Chemotherapy Effect; Amyloid Cardiomyopathy; Congestive Heart Failure
• Interventions: Diagnostic Test: Left and Right Ventricular Global Strain Imaging

• Registration Number: NCT05452850
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-07
• Study First Posted: 2022-07-11
• Study Start: 2022-08-11
• Status Verified: 2023-09
• Primary Completion: 2023-09-26
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Study Completion: 2023-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Light Chain Cardiac Amyloidosis	Left and Right Ventricular Global Strain Imaging	Participants with light chain cardiac amyloidosis actively receiving chemotherapy or undergoing autologous bone marrow transplant

Primary Outcome Measures

Name	Time	Method
The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis	Change from Baseline left and right ventricular global strain at 1 year	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging	Baseline, and 1st, 3rd, 6th, 12th Month follow-up	Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging was planned as a secondary objective.

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Fatih, Turkey