Cardiomyopathy Due to DrugNCT04547465
2D Speckle-tracking Echocardiography in Chemotherapy-induced Cardiomyopathy With Cardiovascular Risk Factors
An observational study of Cardiomyopathy Due to Drug and Breast Cancer, run by Gia Dinh People Hospital at 1 site in Vietnam.
Trial summary
The aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiomyopathy Due to Drug, Breast Cancer, Cardiovascular Risk Factor
- What is being tested?
- Echocardiography
- How many people
- 300 participants
- Where
- 1 siteVietnam
- Study dates
- 15 Sep 2020to 30 Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients treated by anthracycline and/or trastuzumab with at least one of the cardiovascular risk factors
Who may be able to join
- Breast cancer patients treated by anthracycline and/or trastuzumab
- Have at least one of these cardiovascular risks: age > 60, hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, chronic kidney disease, obesity, family history of cardiovascular diseases.
Who cannot join
- Left ventricular ejection fraction < 50% before chemotherapy
- Chronic heart failure with NYHA functional class >= II
- Significant valvular stenosis/regurgitation
- Acute heart failure due to acute coronary syndrome during follow-up
Trial locations and contacts
1 site in 1 country.
Vietnam1 site, 1 recruiting
- Recruiting
Nguyen Hoang Hai
Ho Chi Minh City
Nguyen H. Hai, Ph.D, +84-908247359
About this study
Official title: The Role of 2D Speckle-tracking Echocardiography in Diagnosis Chemotherapy-induced Cardiomyopathy in Breast Cancer Patients With High Cardiovascular Risk Factors
The aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks
Read the detailed description
Chemotherapy induced cardiomyopathy is a serious adverse effect of anticancer treatments with poor long-term prognosis. In addition to the cumulative dose of anthracycline and trastuzumab, cardiovascular risks have been proven to be the "second hit" when dealing with chemotherapy related cardiomyopathy in breast cancer patients. Speckle-tracking echocardiography have had robust evidence in diagnosis the early stage of left ventricular dysfunction in various types of cancer treated by cardiotoxicity drugs. However, data is still lacking regarding the role of speckle-tracking echocardiography in breast cancer patients with cardiovascular risk
- Being tested
- Echocardiography
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
2D Speckle-tracking echocardiography
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk
the incidence
Measured: two year follow-up
The kinetics of left ventricular global longitudinal strain (LV-GLS) in breast cancer patients treated by anthracycline and/or trastuzumab
global longitudinal strain (percentage)
Measured: two year follow-up
The cut-off value of global longitudinal strain (GLS) to predict chemotherapy induced cardiomyopathy in breast cancer patients treated by anthracycline and/or trastuzumab
global longitudinal strain (percentage)
Measured: two year follow-up
The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab
longitudinal strain (percentage)
Measured: two year follow-up
The kinetics of left atrial longitudinal strain (LASr, LAScd, LASct) in breast cancer patients treated by anthracycline and/or trastuzumab
longitudinal strain (percentage)
Measured: two year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study start15 Sep 2020
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiomyopathy Due to DrugStudies 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gia Dinh People Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hai H. Nguyen, Ph.D, Principal investigator, Cardiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04547465
- Sponsor's protocol ID
- 230/HĐĐĐ-ĐHYD
- Status last verified
- Aug 2022
- First submitted
- 6 Sep 2020
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 2D Speckle-tracking Echocardiography in Diagnosis Chemotherapy-induced Cardiomyopathy in Breast Cancer Patients With High Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT04547465
- Acronym / sponsor ID
- 230/HĐĐĐ-ĐHYD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Gia Dinh People HospitalUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 14 Sep 2020 (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 aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks
Detailed description
Chemotherapy induced cardiomyopathy is a serious adverse effect of anticancer treatments with poor long-term prognosis. In addition to the cumulative dose of anthracycline and trastuzumab, cardiovascular risks have been proven to be the "second hit" when dealing with chemotherapy related cardiomyopathy in breast cancer patients. Speckle-tracking echocardiography have had robust evidence in diagnosis the early stage of left ventricular dysfunction in various types of cancer treated by cardiotoxicity drugs. However, data is still lacking regarding the role of speckle-tracking echocardiography in breast cancer patients with cardiovascular risk
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients treated by anthracycline and/or trastuzumab with at least one of the cardiovascular risk factors
Key inclusion criteria (2 listed)
- Breast cancer patients treated by anthracycline and/or trastuzumab
- Have at least one of these cardiovascular risks: age > 60, hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, chronic kidney disease, obesity, family history of cardiovascular diseases.
Key exclusion criteria (4 listed)
- Left ventricular ejection fraction < 50% before chemotherapy
- Chronic heart failure with NYHA functional class >= II
- Significant valvular stenosis/regurgitation
- Acute heart failure due to acute coronary syndrome during follow-up
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 |
|---|---|---|
| Echocardiography2D Speckle-tracking echocardiography | Diagnostic test | – |
Primary outcome
The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk
Time frame: two year follow-up
the incidence
The kinetics of left ventricular global longitudinal strain (LV-GLS) in breast cancer patients treated by anthracycline and/or trastuzumab
Time frame: two year follow-up
global longitudinal strain (percentage)
The cut-off value of global longitudinal strain (GLS) to predict chemotherapy induced cardiomyopathy in breast cancer patients treated by anthracycline and/or trastuzumab
Time frame: two year follow-up
global longitudinal strain (percentage)
The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab
Time frame: two year follow-up
longitudinal strain (percentage)
The kinetics of left atrial longitudinal strain (LASr, LAScd, LASct) in breast cancer patients treated by anthracycline and/or trastuzumab
Time frame: two year follow-up
longitudinal strain (percentage)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- 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.
Hai H. Nguyen, Ph.D principal investigator
Cardiology Department
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 Cardiomyopathy Due to Drug and Breast Cancer, run by Gia Dinh People Hospital at 1 site in Vietnam.
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 2 inclusion and 4 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 8 Aug 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 Vietnam. 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?
Contact Nhat M. Giang, M.D (+84919963999, minhnhat210189@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk (time frame: two year follow-up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.