Acute decompensated heart failure (ADHF) is one of the major causes of hospitalization and mortality worldwide. Despite advances in medical treatments, managing ADHF remains complex, especially in high-risk populations. Levosimendan, a calcium sensitizer that improves myocardial contractility and reduces complications associated with acute decompensated heart failure, has shown potential in improving outcomes in these patients. The present study aims to evaluate the efficacy and safety of levosimendan in patients with ADHF in a real-world clinical setting.
This pragmatic, multicenter, randomized, controlled trial will include adult patients diagnosed with ADHF in two groups: one receiving levosimendan infusion, and the other receiving standard care for heart failure management, according to the most up-to-date clinical protocols. The study is designed to assess both the efficacy and safety of levosimendan, comparing it with the current standard of care.
The primary endpoint of the study will be a clinical composite outcome measured from the NYHA functional classification of heart failure and patient global assessment. Secondary endpoints will include change in serum pro-BNP levels, clinical outcome of heart failure, changes in dyspnea status, all-cause and cardiac mortality. Safety endpoints, including adverse events, will also be systematically recorded and analyzed. Adverse events will be closely monitored, categorized as either mild, moderate, or severe, and their potential association with the treatment will be assessed.
Data collection will occur at baseline and during subsequent follow-up visits at 6 hours, 24 hours, 5 days (or day of discharge), and 90 days post-treatment. Key efficacy measures will be obtained through clinical evaluations and laboratory tests, including blood pressure, electrocardiogram (ECG) findings, and NT-proBNP serum levels. The statistical analysis will follow an intention-to-treat (ITT) and Per protocol (PP) approach to account for all enrolled patients, ensuring robust and generalizable findings. This study will be conducted in accordance with Good Clinical Practice (GCP) guidelines and ethical standards outlined in the Declaration of Helsinki, prioritizing participant safety and scientific rigor throughout the study.
12 The results of this trial will provide critical insights into the potential benefits of levosimendan for treating ADHF, and could potentially inform clinical decision-making, offering a more effective therapeutic option in managing this life-threatening condition.
Phase:
PHASE2
Details
Lead Sponsor:
Chittagong Medical College
Collaborators:
Beacon Pharmaceuticals PLC Pi Research and Development Center, Bangladesh