Effects of Levosimendan on Heart Function After TAVR in Heart Failure Patients
Regulation of Cardiac Function After TAVR in Patients With Severe Aortic Stenosis Combined With Cardiac Insufficiency: a Prospective, Single-center, Randomized Controlled Study
This study is testing if the drug levosimendan can help improve heart function in patients with severe aortic stenosis and heart failure after they have a TAVR procedure.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 65 Years to 85 Years |
| Sex | All |
| Sponsor | Qilu Hospital of Shandong University Academic / other |
| Locations | 1 site (Jinan, 山东省) |
| Trial ID | NCT06196177 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of levosimendan, a positive inotropic drug, on cardiac function in patients with severe aortic stenosis and heart failure following transcatheter aortic valve replacement (TAVR). A total of 112 patients will be recruited and randomly assigned to receive either levosimendan or a control treatment after their TAVR procedure. The study will monitor various cardiac parameters, including blood pressure, echocardiography results, and biomarkers, at multiple time points post-surgery. The goal is to assess the efficacy of levosimendan in improving heart function and reducing cardiovascular events in this high-risk population.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 65-85 years with severe aortic valve stenosis and reduced left ventricular ejection fraction undergoing TAVR.
Not a fit: Patients with severe hepatic or renal impairment, significant hypotension, or other serious comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve heart function and outcomes for patients with severe aortic stenosis and heart failure.
How similar studies have performed: Previous studies have shown promising results with levosimendan in various cardiac settings, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients aged 65-85 years undergoing TAVR; * Echocardiography diagnosed severe aortic valve stenosis with LVEF\<0.4； * Prior to the initiation of the study, the patients or their legal representatives signed the informed consent form. Exclusion Criteria: * Adverse reactions to levosimendan or other excipients; * In addition to the aortic valve disease, still with cardiac mechanical obstructive diseases; * Patients with severe hepatic and renal impairment (creatinine clearance \<30ml/min); * Patients with severe hypotension (SBP\<90mmHg or DBP\<60mmHg) and ventricular tachycardia, ventricular fibrillation, and frequent premature ventricular contractions. * Severe complications occurred during TAVR. * Are involved in other clinical studies * Other clinically significant respiratory, digestive, hematological, infectious, immune, endocrine, neuropsychiatric, tumor diseases, etc.
Where this trial is running
Jinan, 山东省
- QIlu hospital of shandong university — Jinan, 山东省, China (Recruiting)
Study contacts
- Study coordinator: guipeng an, M.D.
- Email: guipengan@hotmail.com
- Phone: 18560086587
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.