Clinical trial NCT07262723: Levosimendan in Acute Decompensated Heart Failure
Official title: Efficacy and Safety of Levosimendan in Patients With Acute Decompensated Heart Failure: A Real-World Evidence
Conditions: Acute Decompensated Heart Failure (ADHF)
Summary: 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.
Interventions:
description: Levosimendan is a calcium-sensitizing inotrope with vasodilatory effects, enhancing heart contractility without raising oxygen demand and promoting vascular relaxation. In this trial, patients will be randomized to receive either standard care alone or standard care plus levosimendan (0.1 μg/kg/min IV infusion for 24 hours).
name: Levosimendan
type: Drug
description: Participants will receive standard care for acute decompensated heart failure according to the 2024 ACC Guideline for the Management of Heart Failure. This may include intravenous diuretics, vasodilators, inotropes, renin-angiotensin system inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and SGLT2 inhibitors as clinically indicated.
name: Standard care
type: Other
Study arms:
design_group_description: Participants will receive standard guideline-directed care for heart failure plus levosimendan infusion. Levosimendan will be administered as a continuous intravenous infusion at 0.1 μg/kg/min for 24 hours, in addition to standard therapy.
design_group_title: Intervention Arm
design_group_type: Experimental
design_group_description: Participants will receive standard guideline-directed care for heart failure according to the 2024 ACC guidelines. This may include diuretics, vasodilators, inotropes, and other evidence-based therapies as clinically indicated.
design_group_title: Standard Care
design_group_type: Active Comparator
Sponsor: Chittagong Medical College
Collaborators: Beacon Pharmaceuticals Plc
Drug name mappings:
name: 左西孟旦
lang: CN
name: Levosimendan
lang: EN