Evaluating the impact of a gene on heart failure treatment with levosimendan
Study on the Correlation Between NAT2(N-acetyltransferase2) Gene Polymorphism and CrCl(Creatine Clreance) and the Efficacy and Safety of Levosimendan in Patients With Severe Heart Failure
This study is testing if a gene affects how well the heart medication levosimendan works for Chinese patients with severe heart failure, while also looking at personalized dosing strategies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 352 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Qianfoshan Hospital Academic / other |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT05913271 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the NAT2 gene polymorphism and creatinine clearance in patients suffering from severe heart failure. It aims to assess the efficacy and safety of levosimendan, a medication used to improve heart function, in a specific population of Chinese patients. The study will also focus on developing individualized dosing strategies based on pharmacokinetics and patient characteristics. By re-evaluating the drug's performance post-marketing, the study seeks to optimize treatment for heart failure patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 diagnosed with severe heart failure and a left ventricular ejection fraction of less than 50%.
Not a fit: Patients with mild heart failure (NYHA class I-II) or severe comorbid conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized treatment strategies for patients with severe heart failure.
How similar studies have performed: While this approach is focused on a specific gene and population, similar studies have shown promise in tailoring heart failure treatments based on genetic factors.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-80 years old * Patients who were clearly diagnosed with heart failure ( cardiac insufficiency ) and LVEF(Left Ventricular Ejection Fraction) \< 50 %, and were judged by the physician to need and agree to use levosimendan to maintain hemodynamic stability * Sign informed consent Exclusion Criteria: * chronic heart failure and New York Heart Association ( NYHA ) class I \~ II * Complicated with infective endocarditis, aortic dissection, severe liver dysfunction ( child-pugh C ), severe renal insufficiency ( CrCl \< 30 ml / min ), hypertrophic obstructive cardiomyopathy, ventricular assist device or surgical cardiac surgery within 30 days before the use of levosimendan * Patients with severe ventricular arrhythmia 1 within 24 hours before levosimendan and systolic blood pressure 100 times / min within 2 hours before levosimendan * During hospitalization, other positive inotropic drugs 2 were used when levosimendan was intravenously pumped or dripped, excluding the use of catecholamines for rescue * received positive inotropic drug 2 treatment in the last 30 days * Lack of serum creatinine, brain natriuretic peptide or brain natriuretic peptide precursor, serum total bilirubin, cardiac ultrasound baseline ( within 14 days before using levosimendan ) data * pregnant and lactating women
Where this trial is running
Jinan, Shandong
- First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province ) — Jinan, Shandong, China (Recruiting)
Study contacts
- Principal investigator: Yi Han, doctorate — First Affiliated Hospital of Shandong First Medical University ( Qianfoshan Hospital of Shandong Province )
- Study coordinator: Yi Han, doctorate
- Email: 15552565120@163.com
- Phone: 15552565120
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.