The Efficacy and Safety of ARNI on the Outcome of Advance... | NCT07261098

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

NCT07261098

Sponsor

Shanghai Chest Hospital

Status

Not yet recruiting

Last Update Posted

Dec 3, 2025Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

Advanced Lung Cancer

Interventions

ARNI
Anti-hypertensive drugs except ARNI

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Nov 21, 2025

First Submission Date that Met QC Criteria

Nov 21, 2025

First Posted Date

Dec 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2025

Last Update Posted Date

Dec 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control group	Active Comparator	The patients of this cohort take anti-hypertensive medicine other than ARNI, such as angiotensin receptor blockers, calcium channel blockers, and diuretics.	Drug: Anti-hypertensive drugs except ARNI
ARNI group	Experimental	The patients of this cohort take ARNI as anti-hypertensive medicine.	Drug: ARNI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARNI	Drug	ARNI is prescribed for lung cancer patients with concurrent arterial hypertension	ARNI group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	Patients deceased during follow-up regardless of the cause.	From enrollment to the end of treatment at 24 months

Secondary Outcomes

Measure	Description	Time Frame
Major adverse cardiovascular event	Major adverse cardiovascular events include cardiovascular death, hospitalization due to heart failure, acute coronary syndrome, and myocardial infarction.	From enrollment to the end of treatment at 24 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided