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

Active, not recruiting

• Conditions: Left Atrial Abnormality; Amyloid Cardiomyopathy; Congestive Heart Failure; Supraventricular Arrhythmia
• Interventions: Diagnostic Test: Left Atrial Strain Imaging; Diagnostic Test: Electrocardiography

• Registration Number: NCT05448716
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-07-02
• Study First Submitted QC: 2022-07-02
• Study First Posted: 2022-07-07
• Study Start: 2022-08-10
• 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, 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
The prognostic significance of longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapy in cardiac light chain amyloidosis	Baseline, and 1st, 3rd, 6th, 12th Month follow-up	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Istanbul University-Cerrahpasa; 🇹🇷 Istanbul, Turkey