Evaluating the utility of H-FABP to predict cardiac dysfunction in cancer patients on Anthracycline chemotherapy, Her 2 Targeted therapy and Immunotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary outcome
研究概览
简要总结
This prospective cross-sectional study aims to evaluate the utility of Heart-type Fatty Acid Binding Protein (H-FABP) as an early biomarker for detecting cardiac dysfunction in cancer patients undergoing Anthracycline-based chemotherapy, HER2-targeted therapy, and Immune Checkpoint Inhibitor (ICI) treatment. A total of 100 patients will be enrolled over one year and assessed for cardiac toxicity using H-FABP, Troponin I/T, CK-MB, NT-proBNP, and CRP at baseline, 3 months, and 6 months. Cardiac function will be evaluated using ECG and 2D Echocardiography with Global Longitudinal Strain (GLS). The study will explore the correlation between H-FABP and other biomarkers with GLS changes to determine their predictive value for subclinical cardiotoxicity. Given the high mortality associated with ICI-related myocarditis and the known cardiotoxic potential of anthracyclines and HER2 therapies, early detection is critical. H-FABP, due to its rapid release following myocardial injury, may offer a sensitive tool for early intervention, potentially reducing treatment interruptions and improving patient outcomes. Statistical analysis will involve ANOVA and correlation tests, with significance set at p<0.05. The findings could support integrating H-FABP into routine monitoring protocols, enhancing cardioprotection and allowing safer, uninterrupted cancer therapy delivery.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Age above 18 years and both genders.
- •Histologically diagnosed metastatic and non-metastatic carcinoma planned for Anthracycline- based Chemotherapy, Immunotherapy & HER 2 NEU targeted therapy.
排除标准
- •Any previous existing LV dysfunction.
- •Any pre-existing ischemic heart disease, Arrhythmias, and congenital heart disease.
- •Any history of previously treated or ongoing treatment of heart failure.
- •Gross derangement in any metabolic parameters that can affect GLS, like sepsis and anemia.
结局指标
主要结局
Primary outcome
时间窗: Baseline, 3rd month and 6th month
To determine the H FABP as a cardiac biomarker in predicting cardiac dysfunction among cancer patients associated with Anthracycline chemotherapy, Immunotherapy and HER 2 NEU targeted therapy
时间窗: Baseline, 3rd month and 6th month
Secondary Outcome
时间窗: Baseline, 3rd month and 6th month
To Find co-relation between H FABP and other cardiac biomarkers like Trop T and NT-pro BNP with GLS AVG to detect the cardiac toxicity associated with Anthracycline chemotherapy,
时间窗: Baseline, 3rd month and 6th month
Immunotherapy and HER 2 NEU targeted therapy
时间窗: Baseline, 3rd month and 6th month
次要结局
- Primary outcome(To determine the H FABP as a cardiac biomarker in predicting cardiac dysfunction among cancer patients associated with Anthracycline chemotherapy, Immunotherapy and HER 2 NEU targeted therapy)
研究者
Pranav Gopal Jawade
Kasturba Medical College and Hospital
