Amyloid CardiomyopathyNCT05452850
Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis
An observational study of Amyloid Cardiomyopathy and Congestive Heart Failure, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Amyloid Cardiomyopathy, Congestive Heart Failure, Chemotherapy Effect
- What is being tested?
- Left and Right Ventricular Global Strain Imaging
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Aug 2022to 30 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Fatih, 34098
About this study
Official title: 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.
Read the 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.
- Being tested
- Left and Right Ventricular Global Strain Imaging
- Keywords
- Cardiac amyloidosis, Cardiomyopathy, Heart failure, Chemotherapy, Echocardiography, Strain imaging
- Medical subject headings
- Amyloid Neuropathies, Familial, Heart Failure, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Left and Right Ventricular Global Strain ImagingDiagnostic test
Also called TomTec AutoStrain Suite Software, Philips Epiq CVx Echocardiography System, Philips X5-1 3D Echocardiography Probe
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.
| Study group | Role | What they receive |
|---|---|---|
| Light Chain Cardiac Amyloidosis | Participants with light chain cardiac amyloidosis actively receiving chemotherapy or undergoing autologous bone marrow transplant Receives: Diagnostic Test: Left and Right Ventricular Global Strain Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Evaluation of the effects of treatment strategies on other cardiac morphological and functional changes in standard echocardiographic imaging was planned as a secondary objective.
Measured: Baseline, and 1st, 3rd, 6th, 12th Month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start11 Aug 2022
- Primary completion26 Sep 2023
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amyloid CardiomyopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deniz Mutlu, Istanbul University - Cerrahpasa
- Investigators
- Burçak Kılıçkıran Avcı, Assoc Prof., Study chair, Istanbul University - CerrahpasaDeniz Mutlu, MD, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05452850
- Sponsor's protocol ID
- 2021-53809
- Status last verified
- Sep 2023
- First submitted
- 2 Jul 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27339491Witteles 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.
PubMed 34396169Bak 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.
PubMed 35811735
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Changes in Left and Right Ventricular Global Strain After Chemotherapy in Cardiac Light Chain Amyloidosis: Prognostic Significance
- ClinicalTrials.gov ID
- NCT05452850
- Acronym / sponsor ID
- 2021-53809
- Keywords
- Cardiac amyloidosis, Cardiomyopathy, Heart failure, Chemotherapy, Echocardiography, Strain imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 11 Aug 2022 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 11 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light Chain Cardiac Amyloidosis | – | Diagnostic Test: Left and Right Ventricular Global Strain ImagingParticipants with light chain cardiac amyloidosis actively receiving chemotherapy or undergoing autologous bone marrow transplant |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Left and Right Ventricular Global Strain ImagingAlso: TomTec AutoStrain Suite Software, Philips Epiq CVx Echocardiography System, Philips X5-1 3D Echocardiography ProbeTwo-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. | Diagnostic test | Light Chain Cardiac Amyloidosis |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Results publication: PubMed 27339491Sperry 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.
- Results publication: PubMed 34396169Witteles 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.
- Results publication: PubMed 35811735Bak 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burçak Kılıçkıran Avcı, Assoc Prof. study chair
Istanbul University - Cerrahpasa
Deniz Mutlu, MD principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amyloid Cardiomyopathy and Congestive Heart Failure, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05452850, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.