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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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
unknown
Estimated enrollment
30 participants
Study completion date
October 30, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations
1 countries · 1 sites
Trial Relationships
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Related Scientific Literature
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
July 2, 2022
Actual (reported)
First Posted
July 7, 2022
Actual (reported)
Study Start
August 10, 2022
Actual (reported)
Primary Completion
September 26, 2023
Actual (reported)
Study Completion
October 30, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Left atrial strainSupraventricular ArrhythmiaHeart failurecardiac amyloidosisAmyloid CardiomyopathyArrhythmiaStrain 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 ImagingDiagnostic Test: Electrocardiography
Interventions
Left Atrial Strain ImagingDiagnostic 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
ElectrocardiographyDiagnostic test
Eligibility Criteria
Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.
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.
Electrocardiography will be taken at baseline and the follow-up periods
Also known as: Mindray BeneHeart R12 ECG system
Light Chain Cardiac Amyloidosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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
Contact the study team to confirm eligibility.
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.
Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis
Study Completion
October 30, 2023
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 28, 2023
Record last verified: 2023-09
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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