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NCT07262723

PHASE2/PHASE3

Levosimendan in Acute Decompensated Heart Failure

Sponsor: Chittagong Medical College

View on ClinicalTrials.gov

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.

Official title: Efficacy and Safety of Levosimendan in Patients With Acute Decompensated Heart Failure: A Real-World Evidence

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

332

Start Date

2025-12-01

Completion Date

2026-12-30

Last Updated

2025-12-04

Healthy Volunteers

Conditions

Acute Decompensated Heart Failure (ADHF)

Interventions

DRUG

Levosimendan

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).

OTHER

Standard care

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.

Inclusion Criteria: * Adult patients (age \>18 years) * Both male and female sex * Having left ventricular dysfunction, evidenced by a left ventricular ejection fraction \<40% within the prior 12 months * Hospitalized for the treatment of ADHF * Remained dyspneic at rest despite treatment with intravenous diuretics (NYHA class IV) * Patients might have received intravenous vasodilators and/or positive inotropic drugs (except amrinone and milrinone), but the infusion rates of these drugs must have remained constant for at least 2 h before entry into the study. Exclusion Criteria: * History of invasive cardiac procedure * Cardiac surgery during lifetime within 3 months prior to screening * Cardiac revascularization within 3 months prior to screening * Left ventricular assist device (LVAD) implantation within 3 months prior to screening * A cardioversion within 4 h prior to screening, or * Cardiac re-synchronization procedure within 30 days prior to screening) * Rhythm disorders (e.g. earlier Torsades de Pointes, increased heart rate) * Severe ventricular outflow obstruction * Angina within 6 h prior to screening * Hypotension (a systolic blood pressure \<90 mmHg) \[Can be included after resuscitation, when SBP will be \>90 mmHg by noradrenaline infusion\] * Uncorrected hypokalemia * CNS disease (e.g. stroke, TIA) * Respiratory (e.g. COPD exacerbation requiring systematic steroids or intubation) * Renal insufficiency (e.g. increased serum creatinine clearance rate \<15 mL/min) * Hepatic impairment (e.g. significant increase in liver enzymes, \>5x the upper limit of normal) * Decompensation from active infection eg, sepsis * Acute bleeding * Patient required blood transfusion or Severe anemia (hemoglobin \<8 g/l) * Serum potassium concentration \<3.5 or \>5.4 mmol/l * Use of amrinone and milrinone prior to screening * A history of hypersensitivity to levosimendan or any of the excipients * Intubated or otherwise unable to communicate * Pregnancy * Post partum cardiomyopathy * Previous participation in a clinical trial with any experimental treatment within the last 30 days

Locations (6)

Chittagong Medical College Hospital, Chattogram

Chittagong, Bangladesh

Chattogram Maa-O-Shishu Hospital Medical College Hospital

Chittagong, Bangladesh

Apollo Imperial Hospital & Max Hospital

Chittagong, Bangladesh

Cox's Bazar Medical College

Cox’s Bāzār, Bangladesh

National Institute of Cardiovascular Diseases

Dhaka, Bangladesh

United Hospital Limited

Dhaka, Bangladesh

Clinical Research Directory

Levosimendan in Acute Decompensated Heart Failure

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (6)