Clinical trial NCT05452850: Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis
Official title: Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis: Prognostic Significance
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Amyloid Cardiomyopathy
Congestive Heart Failure
Chemotherapy Effect
Keywords: Cardiac amyloidosis
Cardiomyopathy
Heart failure
Chemotherapy
Echocardiography
Strain imaging
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-07-11
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 and right ventricular global strain after chemotherapeutic strategies in cardiac light chain amyloidosis.

Detailed description: Light chain 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. In the treatment, chemotherapeutic agents are used that prevent the clonal proliferation of plasma cells in the bone marrow. Although the hematological response is standardized in evaluating the treatment response, there is no adequately effective method for assessing cardiac response. Despite the use of various scores, imaging-based systems continue to be developed to increase the sensitivity of these methods.

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 1 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, PCI 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

Primary outcomes:
measure: The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis
timeFrame: Change from Baseline left and right ventricular global strain at 1 year
Secondary outcomes:
measure: Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging
timeFrame: Baseline, and 1st, 3rd, 6th, 12th Month follow-up
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University-Cerrahpasa
state: Fatih
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: Sperry BW, Ikram A, Hachamovitch R, Valent J, Vranian MN, Phelan D, Hanna M. Efficacy of Chemotherapy for Light-Chain Amyloidosis in Patients Presenting With Symptomatic Heart Failure. J Am Coll Cardiol. 2016 Jun 28;67(25):2941-8. doi: 10.1016/j.jacc.2016.03.593.
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: Bak M, Kim D, Choi JO, Kim K, Kim SJ, Jeon ES. Prognostic Implication of Longitudinal Changes of Left Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis. Front Cardiovasc Med. 2022 Jun 24;9:904878. doi: 10.3389/fcvm.2022.904878. eCollection 2022.