A Prospective Study of the Efficacy and Safety of Angiotensin Receptor-neprilysin Inhibitor in Patients With Advanced Lung Cancer and Concurrent Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- All-cause mortality
研究概览
简要总结
Despite the rapid development of novel anti-cancer therapeutic agents and ensuing improved prognosis, lung cancer remains the leading cause of cancer-related death globally, of which the majority of mortality could be attributed to advanced lung cancer. Hypertension is frequently diagnosed among patients with advanced lung cancer, either a comorbidity or complication, and is associated with increased incidence of cardiac adverse events, such as heart failure, coronary artery disease, and cardiac arrhythmias, hence aggravating patients' prognosis.
Sacubitril/valsartan, a combination of an angiotensin II receptor blocker and neprilysin inhibitor (ARNI), is a novel agent to treat HF and has been approved to treat hypertension in China, of which the cardio-protective effect has been widely acknowledged. Yet current knowledge remains lacking on the influence of ARNI on the prognosis of advanced lung cancer with concurrent hypertension. The present study aimed to investigate the prognostic value of ARNI in patients with advanced lung cancer and concurrent hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent (ICF) and able to understand and comply with the study requirements and assessment schedule.
- •Male or female aged ≥18 years and < 80years at the time of signing the ICF.
- •Histologically or cytologically confirmed advanced lung cancer (TNM III-TNM IV) based on the 8th edition of the AJCC staging system
- •Patients were diagnosed hypertension before the diagnosis of advanced lung cancer
- •ECOG performance status score ≤
- •Adequate organ function during the screening period
排除标准
- •Predicted survival period less than 12 months
- •Female patients if pregnant.
- •Hypersensitivity to any component of ARNI
- •Severe renal dysfunction (eGFR<30ml/min/1.73m2)
- •Severe liver dysfunction (Child-Pugh C)
- •Bilateral renal artery stenosis or solitary renal artery stenosis
- •Refractory hyperkalemia
- •Moderate or severe aortic stenolsis
- •Obstructive hypertrophic cardiomyopathy
研究组 & 干预措施
Control group
The patients of this cohort take anti-hypertensive medicine other than ARNI, such as angiotensin receptor blockers, calcium channel blockers, and diuretics.
干预措施: Anti-hypertensive drugs except ARNI (Drug)
ARNI group
The patients of this cohort take ARNI as anti-hypertensive medicine.
干预措施: ARNI (Drug)
结局指标
主要结局
All-cause mortality
时间窗: From enrollment to the end of treatment at 24 months
Patients deceased during follow-up regardless of the cause.
次要结局
- Major adverse cardiovascular event(From enrollment to the end of treatment at 24 months)
研究者
Liang Zhao
Professor
Shanghai Chest Hospital