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临床试验/CTRI/2025/10/096375
CTRI/2025/10/096375尚未招募不适用

Evaluating the utility of H-FABP to predict cardiac dysfunction in cancer patients on Anthracycline chemotherapy, Her 2 Targeted therapy and Immunotherapy

Pranav Gopal Jawade1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年11月6日最近更新:

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

发起方
Pranav Gopal Jawade
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Pranav Gopal Jawade

Kasturba Medical College and Hospital

研究点 (1)

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