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A phase III clinical trial of recombinant human atrial natriuretic peptide in patients with heart failure

A phase III clinical trial of recombinant human atrial natriuretic peptide in patients with heart failure

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-14005719
Enrollment
Unknown
Registered
2014-12-26
Start date
2009-05-14
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

heart failure

Interventions

treatment group:recombinant human atrial natriuretic peptide added on conventional therapy

Sponsors

State Key Laboratory of Cardiovascular Diseases, Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. new-onset heart failure or acute decompensated chronic heart failure; 2. 18-75 years of age; 3. NYHA class III or IV heart failure; 4. echocardiographically measured left ventricular ejection fraction(LVEF) less than 40%; 5. pulmonary venous congestion or pulmonary edema on chest X-ray (unneccessary in centers without beside X-ray); 6. systolic blood pressure higher than 90 mmHg; 7. written informed consent was obtained; 8. pulmonary capillary wedge pressure (PCWP) higher than 13mmHg in catheter group.

Exclusion criteria

Exclusion criteria: 1. cardiac shock; 2. systolic blood pressure lower than 90 mmHg; 3. possibility of hypovolemia; 4. acute myocardial infarction; 5. uncontrolled or fatal arrhythmia; 6. intractable or uncontrolled infection; 7. hepatic disease, digestive system disease, blood disease, lung disease, nerve disease with clinical significance or disease with serious risk; 8. restrictive or hypertrophic obstructive cardiomyopathy, valvular stenosis, constrictive pericarditis, pulmonary heart disease, active myocarditis or complex congenital heart disease; 9. history of severe asthma or chronic obstructive pulmonary disease; 10. acute heart failure, chronic glomerulonephritis or polycystic kidney; 11. obvious renal function damage:serum creatinine more than 160umol/L; 12. liver function abnormal: AST or ALT more than 3 times of normal level; 13. serum sodium less than 125mmol/L or more than 160mmol/L; 14. pregnant or lactating women; 15. patients that can not stop sodium nitrate, brain natriuretic peptide (BNP), atrial natriuretic peptide (ANP) and diuretics through intravenous drip during the study period; 16. participants of other clinical trial in recent 4 weeks; 17. other diseases that may affect survival, such as cancer, HIV, etc.; 18. possibiliy of history of drug abuse or other diseases that may complicate the recruitment at the discretion of researchers; 19. mental or juridical disability; 20. history of drug allergy; 21. other patients that should be excluded at the discretion of researchers.

Design outcomes

Primary

MeasureTime frame
pulmonary capillary wedge pressure (PCWP);

Secondary

MeasureTime frame
dyspnea;oxygen saturation;arterial blood gas analysis;hemodynamic parameters;urine output;chest X ray;

Countries

China

Contacts

Public ContactGuogan Wang
wangguog@263.net+86 10 88398471

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026