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

I

Istanbul University - Cerrahpasa (IUC)

Status

Active, not recruiting

Conditions

Amyloid Cardiomyopathy
Left Atrial Abnormality
Supraventricular Arrhythmia
Congestive Heart Failure

Treatments

Diagnostic Test: Electrocardiography
Diagnostic Test: Left Atrial Strain Imaging

Study type

Observational

Funder types

Other

Identifiers

NCT05448716
2021-53810

Details and patient eligibility

About

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.

Full 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.

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, 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

Trial design

30 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Deniz Mutlu, MD

Data sourced from clinicaltrials.gov

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