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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Congestive Heart Failure; Supraventricular Arrhythmia; Amyloid Cardiomyopathy; Left Atrial Abnormality
• Intervention / Treatment: Diagnostic test: Left Atrial Strain Imaging; Diagnostic test: Electrocardiography

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 Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34098
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18-90 years 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 will be recruited.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Light Chain Cardiac Amyloidosis; Participants with light chain cardiac amyloidosis actively receiving chemotherapy or undergoing autologous bone marrow transplant

Diagnostic test: Left 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.; Other Names: TomTec AutoStrain Suite Software; Philips Epiq CVx Echocardiography System; Philips X5-1 3D Echocardiography Probe; Diagnostic test: Electrocardiography; Electrocardiography will be taken at baseline and the follow-up periods; Other Names: Mindray BeneHeart R12 ECG system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Investigators: Study Chair: Burçak Kılıçkıran Avcı, Assoc Prof., Istanbul University - Cerrahpasa (IUC); Principal Investigator: Deniz Mutlu, MD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

General Publications

• Witteles RM, Liedtke M. AL Amyloidosis for the Cardiologist and Oncologist: Epidemiology, Diagnosis, and Management. JACC CardioOncol. 2019 Sep 24;1(1):117-130. doi: 10.1016/j.jaccao.2019.08.002. eCollection 2019 Sep.
• Badano LP, Kolias TJ, Muraru D, Abraham TP, Aurigemma G, Edvardsen T, D'Hooge J, Donal E, Fraser AG, Marwick T, Mertens L, Popescu BA, Sengupta PP, Lancellotti P, Thomas JD, Voigt JU; Industry representatives; Reviewers: This document was reviewed by members of the 2016-2018 EACVI Scientific Documents Committee. Standardization of left atrial, right ventricular, and right atrial deformation imaging using two-dimensional speckle tracking echocardiography: a consensus document of the EACVI/ASE/Industry Task Force to standardize deformation imaging. Eur Heart J Cardiovasc Imaging. 2018 Jun 1;19(6):591-600. doi: 10.1093/ehjci/jey042. Erratum In: Eur Heart J Cardiovasc Imaging. 2018 Jul 1;19(7):830-833.
• Inoue K, Kawakami H, Akazawa Y, Higashi H, Higaki T, Yamaguchi O. Echocardiographic Assessment of Atrial Function: From Basic Mechanics to Specific Cardiac Diseases. J Cardiovasc Dev Dis. 2022 Feb 27;9(3):68. doi: 10.3390/jcdd9030068.
• Hartnett J, Jaber W, Maurer M, Sperry B, Hanna M, Collier P, Patel DR, Wazni OM, Donnellan E. Electrophysiological Manifestations of Cardiac Amyloidosis: JACC: CardioOncology State-of-the-Art Review. JACC CardioOncol. 2021 Oct 19;3(4):506-515. doi: 10.1016/j.jaccao.2021.07.010. eCollection 2021 Oct.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): September 26, 2023
• Study Completion (Estimated): October 30, 2023

Study Registration Dates

• First Submitted: July 2, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Arrhythmia; Heart failure; cardiac amyloidosis; Amyloid Cardiomyopathy; Left atrial strain; Supraventricular Arrhythmia; Strain Imaging
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Metabolic Diseases; Wounds and Injuries; Proteostasis Deficiencies; Heart Failure; Amyloidosis; Arrhythmias, Cardiac; Cardiomyopathies; Sprains and Strains
• Other Study ID Numbers: 2021-53810

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No