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

September 26, 2023 updated by: Deniz Mutlu, Istanbul University - Cerrahpasa (IUC)

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Fatih
      • Istanbul, Fatih, Turkey, 34098
        • Istanbul University-Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
Other Names:
  • TomTec AutoStrain Suite Software
  • Philips Epiq CVx Echocardiography System
  • Philips X5-1 3D Echocardiography Probe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The longitudinal changes in left and right ventricular global strain after chemotherapy in cardiac light chain amyloidosis
Time Frame: Change from Baseline left and right ventricular global strain at 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging
Time Frame: Baseline, and 1st, 3rd, 6th, 12th Month follow-up
Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging was planned as a secondary objective.
Baseline, and 1st, 3rd, 6th, 12th Month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Study Chair: Burçak Kılıçkıran Avcı, Assoc Prof., Istanbul University - Cerrahpasa (IUC)
  • Principal Investigator: Deniz Mutlu, MD, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Actual)

September 26, 2023

Study Completion (Estimated)

October 30, 2023

Study Registration Dates

First Submitted

July 2, 2022

First Submitted That Met QC Criteria

July 7, 2022

First Posted (Actual)

July 11, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-53809

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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