Early Specialized Cardiovascular Intervention Based on Impedance Cardiography in Locally Advanced Non-small Cell Lung Cancer Patients
NCT ID: NCT04980716
Last Updated: 2025-11-18
Study Results
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Basic Information
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RECRUITING
PHASE3
524 participants
INTERVENTIONAL
2021-06-01
2026-07-01
Brief Summary
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Detailed Description
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The evaluation and intervention timepoints include: Before neoadjuvant therapy, before radiotherapy, Mid-radiotherapy, 2 months after the completion of radiotherapy, every 6 months thereafter for up to 2 years post-radiotherapy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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The early intervention group
The early intervention group: evaluation and intervention based on impedance cardiography results at multiple timepoints. Specific intervention measures include:
1. cardiovascular drug treatment: based on the increase and decrease of the "Golden Triangle"
1. ACEI, perindopril tert-butyrate 4mg qd
2. β receptor antagonist, metoprolol succinate 47.5mg qd
3. Spironolactone 20mg qd
4. Drugs to improve myocardial metabolism: trimetazidine hydrochloride 35 mg bid
5. Other therapeutic drugs include: loop diuretics, ARNI, sinus node If current selection specific inhibitors, statins, antiplatelet aggregation and nitrate drugs, etc.
2. Exercise intervention: exercise prescription based on the initial cardiopulmonary exercise test results.
Multiple cardiovascular drugs related to "Golden Triangle"
Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
The control group
This group will be under observation. When cardiovascular events (including ischemic cardiomyopathy, heart failure, arrhythmia requiring treatment, pericardial disease requiring treatment, valvular disease, etc.) happen, a cardiovascular specialist assessment and intervention will be given.
No interventions assigned to this group
Interventions
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Multiple cardiovascular drugs related to "Golden Triangle"
Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
Eligibility Criteria
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Inclusion Criteria
2. Plan to receive radical radiotherapy and chemotherapy ± immunotherapy;
3. Male or female between 18 and 75 years old;
4. Life expectancy ≥ 12 weeks;
5. The World Health Organization (WHO) PS score is 0 or 1;
6. Organ and bone marrow function meet the following conditions: Forced expiratory volume per second (FEV1) ≥1000 ml; absolute neutrophil count ≥1.5×10\^9/L; platelets ≥100×10\^9/L; hemoglobin ≥90 g/L ; Serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); alanine aminotransferase and aspartate aminotransferase ≤2.5 times ULN;
7. A signed informed consent form is required before proceeding with any step in the research;
8. There is an abnormality in the initial cardiac output index.
Exclusion Criteria
2. Organ function impairment: FEV1 \<1000ml; absolute neutrophil count \<1.5×10\^9/L; platelets \<100×10\^9/L; hemoglobin \<90 g/ L; Serum creatinine clearance calculated according to Cockcroft-Gault formula \<50 mL/min; serum bilirubin\>1.5 times ULN; alanine aminotransferase and aspartate aminotransferase\>2.5 times ULN;
3. Unstable angina or myocardial infarction occurred in the past month;
4. Arrhythmia that has not been controlled and can cause symptoms or abnormal hemodynamics;
5. Active endocarditis;
6. Symptomatic severe aortic stenosis;
7. Heart failure that has not been controlled;
8. Acute pulmonary embolism, pulmonary infarction or low thrombosis (artery or vein) formation;
9. Suspected or confirmed aortic dissection;
10. Uncontrolled bronchial asthma;
11. Pulmonary edema;
12. Fingertip blood oxygen saturation at rest ≤85%;
13. Acute non-cardiopulmonary diseases (such as infection, renal failure, thyrotoxicosis, etc.) that may affect sports performance or aggravate due to exercise;
14. Mental disorders make it impossible to cooperate.
15. Patients for whom drug intervention is clearly recommended according to the 2022 edition of the European Society of Cardiology Guidelines on Cardio-Oncology.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Hui Liu
Professor
Principal Investigators
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Hui Liu, Professor
Role: PRINCIPAL_INVESTIGATOR
Sun yat-sen universtiy cancer center
Locations
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Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Bo Qiu, Professor
Role: primary
References
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Other Identifiers
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GASTO-1074
Identifier Type: -
Identifier Source: org_study_id
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