Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis

NCT05452850 | Unknown DMC

• 1 other identifier: 2021-53809
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Amyloid Cardiomyopathy; Congestive Heart Failure; Chemotherapy Effect

Keywords

Cardiac amyloidosis; Cardiomyopathy; Heart failure; Chemotherapy; Echocardiography; Strain imaging

Outcome Measures

Primary Outcomes (1)

• The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis

  In this study, the effects of treatment strategies on left and right ventricular global and regional strain 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.

  Change from Baseline left and right ventricular global strain at 1 year

Secondary Outcomes (1)

• Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging

  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 and Right Ventricular Global Strain Imaging

Interventions

Left and Right Ventricular Global Strain Imaging DIAGNOSTIC_TEST

Two-dimensional, color Doppler, spectral Doppler, and 3D digital echocardiographic image 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

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, 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Fatih, 34098, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 27339491 RESULT

• 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

• 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.

  PMID: 35811735 RESULT

MeSH Terms

Conditions

Amyloid Neuropathies, Familial; Heart Failure; Cardiomyopathies

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

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 11, 2022
• Study Start: August 11, 2022
• Primary Completion: September 26, 2023
• Study Completion: October 30, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

TU (1)