Evaluation and Management of Cardio Toxicity in Oncologic Patients

Heart Failure Clinical Trial

Official title:

Evaluation and Management of Cardio Toxicity in Oncologic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02818517
• Other study ID #: TASMC-16-UC-0228-16-TLV-CTIL
• Status: Recruiting
• Start date: August 1, 2016
• Est. completion date: December 31, 2031

Study information

• Verified date: February 2022
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Michal Laufer Perl, MD
• Phone: 972-527360430
• Email: michalpela[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2031
• Est. primary completion date: November 30, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patient evaluated in the cardio-oncology clinic in Tel Aviv MC

Exclusion Criteria:

• In the prospective Study - patients not sign an informed consent form.

Exclusion criteria experiment:

Patient reluctance to continue the study.

Related Conditions & MeSH terms

• Cardiotoxicity
• Heart Failure

Intervention

Other:
• ACE inhibitors
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 blockers
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.

Locations

Country	Name	City	State
Israel	Tel Aviv Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ECho-global strain	Predictor of reduction Ejection Fraction	2 years
Primary	Troponin (ng/ml)	Predictor of reduction Heart failure	2 years
Primary	ACE inhibitor and beta blocker treatment	estimating the effect of ACE inhibitors and beta blockers preventive treatment for heart failure due to chemotherapy.	2 years
Primary	BNP (PG/ML)	Predictor of reduction Heart failure	2 years