The Efficacy and Safety of ARNI on the Outcome of Advanced Lung Cancer With Concurrent Hypertension
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ARNI, Anti-hypertensive drugs except ARNI.
- Who it may be relevant to
- Registry conditions: Advanced Lung Cancer. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of the Efficacy and Safety of Angiotensin Receptor-neprilysin Inhibitor in Patients With Advanced Lung Cancer and Concurrent Hypertension
Overview
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.
Interventions
- Drug ARNI
ARNI is prescribed for lung cancer patients with concurrent arterial hypertension - Drug Anti-hypertensive drugs except ARNI
Anti-hypertensive drugs except ARNI
Primary outcome measures
- All-cause mortality [Time frame: From enrollment to the end of treatment at 24 months]
Secondary outcome measures (1)
- Major adverse cardiovascular event [Time frame: From enrollment to the end of treatment at 24 months]
Eligibility criteria
Inclusion criteria
- 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 ≤ 1.
- Adequate organ function during the screening period
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07261098 · 2025IIT-ARNI-0001