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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05448716
Enrollment
30
Registered
2022-07-07
Start date
2022-08-10
Completion date
2023-10-30
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyloid Cardiomyopathy, Congestive Heart Failure, Left Atrial Abnormality, Supraventricular Arrhythmia

Keywords

Left atrial strain, Supraventricular Arrhythmia, Heart failure, cardiac amyloidosis, Amyloid Cardiomyopathy, Arrhythmia, Strain Imaging

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.

Interventions

DIAGNOSTIC_TESTLeft Atrial Strain Imaging

Two-dimensional, color Doppler, spectral Doppler 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.

DIAGNOSTIC_TESTElectrocardiography

Electrocardiography will be taken at baseline and the follow-up periods

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The prognostic significance of longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapy in cardiac light chain amyloidosisBaseline, and 1st, 3rd, 6th, 12th Month follow-upIn 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

MeasureTime frameDescription
Evaluation of the effects of treatment strategies on arrhythmia burdenBaseline, and 1st, 3rd, 6th, 12th Month follow-upBy obtaining the serial ECG records, arrhythmia burden will be recorded/

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026