Clinical trial NCT05448716: Left Atrial Strain and Supraventricular Arrhythmia Burden in Cardiac Light Chain Amyloidosis Following Chemotherapy
Official title: Longitudinal Changes in Left Atrial Strain and Supraventricular Arrhythmia Burden in Cardiac Light Chain Amyloidosis Patients Following Chemotherapy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The prognostic significance of longitudinal changes in left atrial strain and supraventricular arrhythmia burden after chemotherapy in cardiac light chain amyloidosis
timeFrame: Baseline, and 1st, 3rd, 6th, 12th Month follow-up
Secondary outcomes:
measure: Evaluation of the effects of treatment strategies on arrhythmia burden
timeFrame: Baseline, and 1st, 3rd, 6th, 12th Month follow-up
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Burçak Kılıçkıran Avcı, Assoc Prof.
role: STUDY_CHAIR
affiliation: Istanbul University - Cerrahpasa
name: Deniz Mutlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.