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A prospective, multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of recombinant human brain natriuretic peptide in improving type 3 pulmonary hypertension

A prospective, multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of recombinant human brain natriuretic peptide in improving type 3 pulmonary hypertension

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200065596
Enrollment
Unknown
Registered
2022-11-09
Start date
2022-11-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 3 pulmonary hypertension

Interventions

Experimental group:recombinant human brain natriuretic peptide
Control group:placebo

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Hospitalized patients with acute exacerbation of chronic lung diseases, including: chronic obstructive pulmonary disease, bronchiectasis, obsolete pulmonary tuberculosis, obstructive sleep apnea hypopnea syndrome and thoracic or spinal deformity; 2. At rest, the systolic pressure of pulmonary artery measured by right heart Doppler ultrasound was >= 50mmHg; 3. At rest, the mean pulmonary artery pressure (mPAP) measured by Swan Ganz catheter was >= 25mmHg with PVR >= 3WU and PAWP = 18 years old, weight >= 30kg ~ = II.

Exclusion criteria

Exclusion criteria: 1. Any other types of pulmonary hypertension; 2. Other active respiratory diseases (such as active pulmonary tuberculosis, pulmonary fibrosis, etc.); 3. Patients requiring invasive mechanical ventilation; 4. At rest, PAWP measured by Swan Ganz catheter was >= 15mmhg; 5. Uncontrolled hypertension; 6. Systolic blood pressure = 5 µ 8. At rest, Doppler echocardiography confirmed left ventricular outflow tract obstruction or left ventricular systolic dysfunction (EF <= 55%); 9. Acute coronary syndrome; 10. Severe renal insufficiency (GFR < 30ml / min / 1.73m2); 11. Significant anemia; 12. Milrinone or levosimendan was used within 30 days before screening; 13. Allergic to any component of rhBNP; 14. Participated in other clinical trials within 30 days before screening; 15. Unable to complete the visit task.

Design outcomes

Primary

MeasureTime frame
Mean pulmonary artery pressure (mPAP);

Secondary

MeasureTime frame
Other hemodynamic parameters of pulmonary artery;PASP;6MWD( 6-minute walk distance);WHO fc;Oxygen partial pressure;dyspnea;NT-proBNP;acute event;

Countries

China

Contacts

Public ContactLi Zhao

Shengjing Hospital of China Medical University

lzhaoli@163.com+86 18940251639

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026