Assessing the Efficacy and Safety of Ivabradine as Adjunctive Therapy in Acute Heart Failure: A Prospective Clinical Trial

Authors

  • Ibrahim Shah Associate professor of cardiology Gajju Khan Medical College Swabi
  • Matiullah Khan Assistant Professor/consultant cardiologist, DHQ teaching hospital swabi
  • Akhtar Sher Asistant professor cardiology DHQ Hospital Swabi
  • Saif Ullah FCPS Cardiology
  • Samiullah Khan Associate Professor Cardiology, DHQ-TH/BMC Bannu

Abstract

Objective: To compare the clinical outcome in terms of efficacy and safety of Ivabradine as adjunctive therapy in patients with acute heart failure.

Methods: A prospective clinical trial was conducted involving patients admitted with acute heart failure, who were randomized to receive either standard care alone or standard care with adjunctive Ivabradine therapy. Efficacy endpoints included improvement in symptoms, left ventricular ejection fraction (LVEF), and reduction in heart rate. Safety endpoints encompassed adverse events, including bradycardia and hypotension. Data were collected at baseline, during treatment, and at follow-up visits.

Results: The mean age (67.5 vs. 68.2 years), Gender distribution, mean ejection fraction (35.7 ± 5.2 vs 36.1 ± 4.8), NYHA class, and prevalent comorbidities were comparable between both groups. The mortality rate (10% vs. 15%), and hospital readmissions (20% vs. 30%, p=0.12) showed no significant difference between both groups. The improvement in NYHA class (65% vs. 50%, p=0.04) was significantly (P-value > 0.05) higher in the treatment group. Treatment group demonstrated a significantly greater increase in ejection fraction (mean change 4.8% vs. 2.3%, p<0.001). Clinical outcomes, heart rate reduction, 6-minute walk distance, reduction in NT-proBNP, all-cause mortality and rate of heart failure hospitalizations were found significantly (p-value < 0.05) better in treatment group.

Conclusion: This prospective clinical trial suggests that Ivabradine as adjunctive therapy in acute heart failure is efficacious in improving symptoms and reducing heart rate, with a favorable safety profile. These findings support the consideration of Ivabradine as an adjunctive treatment option in acute heart failure management.

Keywords: Ivabradine, acute heart failure, adjunctive therapy, clinical trial, efficacy, safety.

Published

2024-07-19

Issue

Section

Original Articles