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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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.

Michal Laufer Perl, MD contact

972-527360430

michalpela@gmail.com

Udi Chorin, MD contact

972-527360498

udichorin5@gmail.com

Israel1 site, 1 recruiting
  • Tel Aviv Medical Center

    Tel Aviv

    Michal Laufer, MD, 972-527360430, michalpela@gmail.com

    Udi Chorin, MD, 972-527360490, udich@tlvmc.gov.il

    Recruiting

Other trials in Israel

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:

  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. 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 groups in NCT02818517
Study groupRoleWhat they receive
Heart failureEvaluating 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.

  1. ECho-global strain

    Predictor of reduction Ejection Fraction

    Measured: 2 years

  2. Troponin (ng/ml)

    Predictor of reduction Heart failure

    Measured: 2 years

  3. 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

  4. 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.

  1. First posted29 Jun 2016 (estimated)
  2. Study start1 Aug 2016
  3. Primary completion30 Nov 2030 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

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
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

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.

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