Heart FailureNCT02818517
Evaluation and Management of Cardio Toxicity in Oncologic Patients
An observational study of Heart Failure, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The survival rate of cancer patients has greatly increased over the past decades' mainly due to early detection and the use of new medications with higher doses and combined protocols. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- ACE inhibitors and beta blockers
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Aug 2016to 31 Dec 2031
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study will be composed of two groups: 1. The retrospective group analysis will include all oncologic patients who were evaluated in the cardio-oncology clinic between 01 January 2014 until 31 May 2016. 2. The prospective group will include all oncologic patients who will be evaluated in the cardio-oncology clinic from 01 June 2016 onward. The patients will sign an informed consent form.
Who may be able to join
- All patient evaluated in the cardio-oncology clinic in Tel Aviv MC
Who cannot join
- In the prospective Study - patients not sign an informed consent form.
- Patient reluctance to continue the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Tel Aviv Medical Center
Tel Aviv
Michal Laufer, MD, 972-527360430, michalpela@gmail.com
Udi Chorin, MD, 972-527360490, udich@tlvmc.gov.il
About this study
The survival rate of cancer patients has greatly increased over the past decades' mainly due to early detection and the use of new medications with higher doses and combined protocols. This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the long term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for many types of cancer. As a result of the increasing number of long-term cancer survivors the magnitude of this problem is growing. Early identification of cardio toxicity can be identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the patient's treatment may prevent the development of cardiac dysfunction. However, currently there are no specific or clear guidelines for the follow-up and management of cardio-toxicity in cancer patients.
The aim of the study: To try to identify who are the patients at increased risk for developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and echocardiogram examination, in purpose of early diagnosis, management and prevention of cardiac events. For achieving this the investigators will build a registry which will include all the oncologic patients going an evaluation in the cardio-oncology clinic in the Tel Aviv Medical Center .
Read the detailed description
The survival rate of cancer patients has greatly increased over the past decades' mainly due to early detection and the use of new medications with higher doses and combined protocols. This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the long term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for many types of cancer. As a result of the increasing number of long-term cancer survivors the magnitude of this problem is growing. Early identification of cardio toxicity can be identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the patient's treatment may prevent the development of cardiac dysfunction. However, currently there are no specific or clear guidelines for the follow-up and management of cardio-toxicity in cancer patients.
The aim of the study: To try to identify who are the patients at increased risk for developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and echocardiogram examination, in purpose of early diagnosis, management and prevention of cardiac events. For achieving this the investigators will build a registry which will include all the oncologic patients going an evaluation in the cardio-oncology clinic in the Tel Aviv Medical Center .
The study will be composed of two groups:
- The retrospective group analysis will include all oncologic patients who were evaluated in the cardio-oncology clinic between 01 January 2014 until 31 May 2016.
- The prospective group will include all oncologic patients who will be evaluated in the cardio-oncology clinic from 01 June 2016 onward.
The patients will sign an informed consent form. The data collected will include demographic: gender, age, duration of hospitalization, diagnosis, symptoms, clinical as well as laboratory, echocardiographic and echicardiogram findings.
The study will be based on unidentified data taken from medical records or medical files of patients. Identified details will be separated in a way that won't enable to review them . All data handling and the separation of the identified data will be done by the Principal Investigator, or sub-investigator in this study, who is in charge of the hearing screening program in Tel Aviv Medical Center.
The study population will include all patients evaluated in the cardio-oncology clinic in our hospital with the diagnosis of cancer and are planned for chemotherapy and/or radiation treatment.
The data collected will include gender, age, cardiovascular risk factors, cardiovascular disease, type of cancer, type of chemotherapy and/or radiation planned, past chemotherapy and/or radiation, vital signs, basic ECG, blood test pre and post therapy (including troponin, CPK, BNP, glucose HBA1C, cholesterol, triglycerides, CRP, WBC, neutrophil count, lymphocyte count, RDW, BNP), Echo at baseline and post therapy (Systolic and diastolic function, strain and valvular function), ACE inhibitor and beta blocker treatment, complication and mortality.
- Conditions
- Heart Failure
- Being tested
- ACE inhibitors, beta blockers
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACE inhibitorsOther
Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure.
beta blockersOther
Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure | Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure. Receives: Other: ACE inhibitors; Other: beta blockers |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECho-global strain
Predictor of reduction Ejection Fraction
Measured: 2 years
Troponin (ng/ml)
Predictor of reduction Heart failure
Measured: 2 years
ACE inhibitor and beta blocker treatment
estimating the effect of ACE inhibitors and beta blockers preventive treatment for heart failure due to chemotherapy.
Measured: 2 years
BNP (PG/ML)
Predictor of reduction Heart failure
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2016 (estimated)
- Study start1 Aug 2016
- Primary completion30 Nov 2030 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Eli Sprecher, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Udi Chorin, MD, Principal investigator, Tel Aviv MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818517
- Sponsor's protocol ID
- TASMC-16-UC-0228-16-TLV-CTIL
- Status last verified
- Feb 2022
- First submitted
- 15 Jun 2016
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shamai S, Rozenbaum Z, Merimsky O, Derakhshesh M, Moshkovits Y, Arnold J, Topilsky Y, Arbel Y, Laufer-Perl M. Cardio-toxicity among patients with sarcoma: a cardio-oncology registry. BMC Cancer. 2020 Jun 30;20(1):609. doi: 10.1186/s12885-020-07104-9.
PubMed 32605637
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Management of Cardio Toxicity in Oncologic Patients
- ClinicalTrials.gov ID
- NCT02818517
- Acronym / sponsor ID
- TASMC-16-UC-0228-16-TLV-CTIL
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 29 Jun 2016 (estimated)
- 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 survival rate of cancer patients has greatly increased over the past decades' mainly due to early detection and the use of new medications with higher doses and combined protocols. This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the long term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for many types of cancer. As a result of the increasing number of long-term cancer survivors the magnitude of this problem is growing. Early identification of cardio toxicity can be identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the patient's treatment may prevent the development of cardiac dysfunction. However, currently there are no specific or clear guidelines for the follow-up and management of cardio-toxicity in cancer patients.
The aim of the study: To try to identify who are the patients at increased risk for developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and echocardiogram examination, in purpose of early diagnosis, management and prevention of cardiac events. For achieving this the investigators will build a registry which will include all the oncologic patients going an evaluation in the cardio-oncology clinic in the Tel Aviv Medical Center .
Detailed description
The survival rate of cancer patients has greatly increased over the past decades' mainly due to early detection and the use of new medications with higher doses and combined protocols. This achievement comes with the price of cardio toxicity, leading to cardiac dysfunction ranged from transient asymptomatic left ventricular dysfunction to cardiac death. In the long term, the risk of death from cardiovascular causes exceeds that of tumor recurrence for many types of cancer. As a result of the increasing number of long-term cancer survivors the magnitude of this problem is growing. Early identification of cardio toxicity can be identified by clinical follow-up and the use of electrocardiography, cardiac biomarkers (Troponin, brain natriuretic peptide) and echocardiogram. Past studies imply that the addition of angiotensin-converting-enzyme inhibitor (ACE inhibitor) and beta blockers to the patient's treatment may prevent the development of cardiac dysfunction. However, currently there are no specific or clear guidelines for the follow-up and management of cardio-toxicity in cancer patients.
The aim of the study: To try to identify who are the patients at increased risk for developing cardio toxicity, by follow up of clinical evaluation, cardiac biomarkers and echocardiogram examination, in purpose of early diagnosis, management and prevention of cardiac events. For achieving this the investigators will build a registry which will include all the oncologic patients going an evaluation in the cardio-oncology clinic in the Tel Aviv Medical Center .
The study will be composed of two groups:
- The retrospective group analysis will include all oncologic patients who were evaluated in the cardio-oncology clinic between 01 January 2014 until 31 May 2016.
- The prospective group will include all oncologic patients who will be evaluated in the cardio-oncology clinic from 01 June 2016 onward.
The patients will sign an informed consent form. The data collected will include demographic: gender, age, duration of hospitalization, diagnosis, symptoms, clinical as well as laboratory, echocardiographic and echicardiogram findings.
The study will be based on unidentified data taken from medical records or medical files of patients. Identified details will be separated in a way that won't enable to review them . All data handling and the separation of the identified data will be done by the Principal Investigator, or sub-investigator in this study, who is in charge of the hearing screening program in Tel Aviv Medical Center.
The study population will include all patients evaluated in the cardio-oncology clinic in our hospital with the diagnosis of cancer and are planned for chemotherapy and/or radiation treatment.
The data collected will include gender, age, cardiovascular risk factors, cardiovascular disease, type of cancer, type of chemotherapy and/or radiation planned, past chemotherapy and/or radiation, vital signs, basic ECG, blood test pre and post therapy (including troponin, CPK, BNP, glucose HBA1C, cholesterol, triglycerides, CRP, WBC, neutrophil count, lymphocyte count, RDW, BNP), Echo at baseline and post therapy (Systolic and diastolic function, strain and valvular function), ACE inhibitor and beta blocker treatment, complication and mortality.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure | – | Other: ACE inhibitors, Other: beta blockersEvaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will be composed of two groups: 1. The retrospective group analysis will include all oncologic patients who were evaluated in the cardio-oncology clinic between 01 January 2014 until 31 May 2016. 2. The prospective group will include all oncologic patients who will be evaluated in the cardio-oncology clinic from 01 June 2016 onward. The patients will sign an informed consent form.
Key inclusion criteria (1 listed)
- All patient evaluated in the cardio-oncology clinic in Tel Aviv MC
Key exclusion criteria (2 listed)
- In the prospective Study - patients not sign an informed consent form.
- Patient reluctance to continue the study.
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 |
|---|---|---|
| ACE inhibitorsEvaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure. | Other | Heart failure |
| beta blockersEvaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure. | Other | Heart failure |
Primary outcome
ECho-global strain
Time frame: 2 years
Predictor of reduction Ejection Fraction
Troponin (ng/ml)
Time frame: 2 years
Predictor of reduction Heart failure
ACE inhibitor and beta blocker treatment
Time frame: 2 years
estimating the effect of ACE inhibitors and beta blockers preventive treatment for heart failure due to chemotherapy.
BNP (PG/ML)
Time frame: 2 years
Predictor of reduction Heart failure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Derived from this study: PubMed 32605637Shamai S, Rozenbaum Z, Merimsky O, Derakhshesh M, Moshkovits Y, Arnold J, Topilsky Y, Arbel Y, Laufer-Perl M. Cardio-toxicity among patients with sarcoma: a cardio-oncology registry. BMC Cancer. 2020 Jun 30;20(1):609. doi: 10.1186/s12885-020-07104-9.
- Individual participant dataSharing planned: No
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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.
Udi Chorin, MD principal investigator
Tel Aviv MC
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 Heart Failure, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 2 Feb 2022. 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 Israel. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michal Laufer Perl, MD (972-527360430, michalpela@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECho-global strain (time frame: 2 years). The study lists 4 primary outcomes in all. 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 NCT02818517, which also lists 1 linked publication.
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 2 Feb 2022.