About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
ARNI
DrugARNI is prescribed for lung cancer patients with concurrent arterial hypertension
Anti-hypertensive drugs except ARNI
DrugAnti-hypertensive drugs except ARNI
Treatment groups
Trial outcomes
Primary outcomes
All-cause mortality
Patients deceased during follow-up regardless of the cause.
Secondary outcomes
Major adverse cardiovascular event
Major adverse cardiovascular events include cardiovascular death, hospitalization due to heart failure, acute coronary syndrome, and myocardial infarction.
Locations
Sponsors and contacts
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