Tissue Doppler Assessment of Right Ventricle Function in Pediatrics Underwent Chemotherapy

• Conditions: Pediatric Cancer Patients

• Registration Number: NCT04831359
• Lead Sponsor: Assiut University

Brief Summary

Tissue Doppler assessment of right ventricular function in newly diagnosed pediatric cancer patients underwent chemotherapy in South Egypt Cancer Institute.

Detailed Description

The incidence of cancer is always increasing and it is predicted that the incidence will increase to 45% by 2030(1). The introduction of new chemotherapeutic agents significantly improved survival, but also revealed large spectrum of cardiotoxicity manifestations (2). There are many factors that increase the risk of cardiotoxicity caused by different chemotherapeutic agents, such as type of chemotherapy, cumulative dose, concomitant or previous radiotherapy, and comorbidities (3). Chemotherapeutic regimens which contain anthracyclines, cyclophosphamide, fluorouracil, cisplatin, taxanes and trastuzumab cause early and late cardiotoxicity (4).

The majority of published studies are focused on left ventricle dysfunction in patients receiving cardiotoxic chemotherapy. However, the right ventricle has been ignored for a long time and a little attention has been directed to show the effect of chemotherapy on right ventricle function. Right ventricle dysfunction is associated with increased morbidity and mortality in many cardiovascular diseases (5). The structure of cardiomyocytes and blood supply between the left and right ventricles are similar. Given the smaller mass and fewer myofibrils of right ventricle, chemotherapy may theoretically cause a more significant impact on it (6).

The right ventricle has a complex geometric shape which includes smooth muscular inflow, outflow and a trabecular apical region so echocardiographic assessment of right ventricle is difficult (7).

M-mode echocardiography, two-dimensional echocardiography, conventional Doppler echocardiography, and myocardial Doppler tissue imaging are all used to evaluate right ventricular function and provide accurate prognostic information especially when used in combination

Study Timeline

• Study Start: 2021-02-20
• Status Verified: 2021-03
• Study First Submitted: 2021-03-29
• Study First Submitted QC: 2021-04-02
• Last Update Submitted: 2021-04-02
• Study First Posted: 2021-04-05
• Last Update Posted: 2021-04-05
• Primary Completion: 2022-02-20
• Study Completion: 2022-04-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients of 1-18 years who are newly diagnosed to have cancer and will be referred to South Egypt cancer institute for receiving chemotherapy

Exclusion Criteria

1. patients with left ventricular (EF) <50% before chemotherapy
2. Previous heart disease
3. Renal failure
4. significant valvular disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of chemotherapy on right ventricular function	Baseline to 45 days	The correlation between echocardiographic parameters of the RV, measured with transthoracic echocardiography before and after chemotherapy

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt