Evaluating the effects of a heart hormone on heart function after a heart attack
Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention
This study is testing whether a heart hormone can help improve heart function in people who have just had a heart attack and are getting treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06463808 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving heart function and ventricular remodeling in patients who have experienced an acute anterior myocardial infarction and are undergoing percutaneous coronary intervention. A total of 100 patients will be randomly assigned to receive either rhBNP or a placebo for three days following their procedure, with both groups receiving standard therapy. The study will follow participants for 24 weeks, measuring changes in specific cardiac biomarkers and echocardiographic parameters to assess heart function. The primary focus is on the levels of NT-proBNP and cardiac troponin T, while secondary outcomes include various echocardiographic measurements.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 who are experiencing their first acute anterior myocardial infarction and are undergoing emergency PCI.
Not a fit: Patients with severe complications, such as cardiogenic shock or significant renal dysfunction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and recovery outcomes for patients after a heart attack.
How similar studies have performed: While the specific use of rhBNP in this context may be novel, similar studies have shown promise in using natriuretic peptides for cardiac conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ). 2. Age 18-75 years old, gender unlimited 3. Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window 4. Successful reflow after interventional therapy ( TIMI = 3 ). 5. To understand and sign the informed consent. Exclusion Criteria： 1. Patients with a history of coronary artery bypass grafting 2. Patients with cardiogenic shock 3. Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors 4. Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture ) 5. Patients with suspected aortic dissection 6. Patients with severe liver and kidney dysfunction 7. Allergic or intolerant to rhBNP. 8. Patients with chronic renal insufficiency requiring long-term dialysis 9. Patients using diuretics during the screening period 10. Pregnant / lactating women 11. Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc
Where this trial is running
Nanjing, Jiangsu
- the First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: LianSheng Wang
- Email: drlswang@njmu.edu.cn
- Phone: 1339078711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.