The Efficacy and Safety of ARNI on the Outcome of Advanced Lung Cancer With Concurrent Hypertension

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorShanghai Chest Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • ARNI

    Drug

    ARNI is prescribed for lung cancer patients with concurrent arterial hypertension

  • Anti-hypertensive drugs except ARNI

    Drug

    Anti-hypertensive drugs except ARNI

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Control groupActive comparator 1 intervention
Group B: ARNI groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All-cause mortality

Patients deceased during follow-up regardless of the cause.

Time frame
From enrollment to the end of treatment at 24 months

Secondary outcomes

1

Major adverse cardiovascular event

Major adverse cardiovascular events include cardiovascular death, hospitalization due to heart failure, acute coronary syndrome, and myocardial infarction.

Time frame
From enrollment to the end of treatment at 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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