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

NCT05448716 | Unknown DMC

• 1 other identifier: 2021-53810
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of the effects of treatment strategies on arrhythmia burden

  Baseline, and 1st, 3rd, 6th, 12th Month follow-up

Study Arms (1)

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; Diagnostic Test: Electrocardiography

Interventions

Left Atrial Strain Imaging DIAGNOSTIC_TEST

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.

Also known as: TomTec AutoStrain Suite Software, Philips Epiq CVx Echocardiography System, Philips X5-1 3D Echocardiography Probe

Light Chain Cardiac Amyloidosis

Electrocardiography DIAGNOSTIC_TEST

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

Also known as: Mindray BeneHeart R12 ECG system

Light Chain Cardiac Amyloidosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 34396169 RESULT

• 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.

  PMID: 29596561 RESULT

• 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.

  PMID: 35323616 RESULT

• 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.

  PMID: 34729522 RESULT

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure; Arrhythmias, Cardiac

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Burçak Kılıçkıran Avcı, Assoc Prof.

  Istanbul University - Cerrahpasa

  STUDY CHAIR

• Deniz Mutlu, MD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2022
• First Posted: July 7, 2022
• Study Start: August 10, 2022
• Primary Completion: September 26, 2023
• Study Completion: October 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

TU (1)