Real-World Effectiveness of Ivabradine in Chinese Patients with Chronic Heart Failure: Interim Analysis of the
Zhou Jingmin1, Xu Yamei1, Zhang Yuhui2
1Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University, #180 Fenglin Road, Xuhui District, Shanghai, 200032, China.
Insights
Ivabradine effectively reduced heart rate and improved quality of life in Chinese patients with chronic heart failure. The treatment was well-tolerated, showing significant benefits in functional class and patient well-being.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Research
Background:
- Chronic heart failure (HF) management often involves heart rate (HR) reduction.
- Ivabradine is known to improve cardiac function and outcomes by lowering HR.
- Real-world data on ivabradine in Chinese HF patients were previously limited.
Purpose of the Study:
- To evaluate the real-world effectiveness and safety of ivabradine in Chinese patients with chronic heart failure.
- To assess the impact of ivabradine on heart rate, functional class, and quality of life.
- To document adverse events associated with ivabradine treatment in this population.
Main Methods:
- Prospective, multicenter, observational study design.
- Inclusion of Chinese adults with HF, left ventricular systolic dysfunction, and resting HR ≥ 75 bpm.
- Primary outcome: change in HR at 6 months; secondary outcomes: NYHA class, KCCQ scores, and adverse events.
Main Results:
- A significant mean HR reduction of 14.5 bpm was observed at 6 months (p < 0.001).
- Significant improvements in New York Heart Association functional class and Kansas City Cardiomyopathy Questionnaire scores were noted (p < 0.001).
- Ivabradine-related adverse events occurred in 6.7% of subjects, most commonly phosphenes and bradycardia.
Conclusions:
- Ivabradine treatment demonstrates significant efficacy in reducing HR in Chinese patients with chronic HF.
- The medication effectively improves functional capacity and quality of life in this patient group.
- Ivabradine was found to be well-tolerated with a low incidence of adverse events.
Background:
Ivabradine improves cardiac function and clinical outcomes in chronic heart failure (HF) by reducing heart rate (HR), but there is a lack of real-world data on its effectiveness and safety in Chinese patients.
Methods:
We designed a prospective, multicenter, observational study of Chinese adults with HF and left ventricular systolic dysfunction, resting HR ≥ 75 beats per minute (bpm), and an indication for ivabradine treatment. An interim analysis was performed using a cut-off date of 31 October 2019. The primary outcome was change in HR at 6 months after the initiation of ivabradine. Secondary endpoints included change in New York Heart Association (NYHA) functional class; quality of life (QoL), measured using the Kansas City Cardiomyopathy Questionnaire (KCCQ); and adverse events (AEs).
Results:
Overall, 655 subjects were included in the interim analysis. Mean reduction in HR from baseline was 13.2 (95% confidence interval [CI] 11.2-15.2) bpm at Month 1, and 14.5 (95% CI 11.8-17.2) bpm at Month 6 (p < 0.001 for both changes). NYHA functional class and KCCQ scores improved significantly over time (p < 0.001 for all comparisons with baseline), indicating amelioration of symptoms and better QoL, respectively. Forty-four subjects (6.7%) reported a total of 60 ivabradine-related AEs, most frequently phosphenes and bradycardia (both n = 6, 0.9%).
Conclusion:
Treatment with ivabradine for 6 months effectively reduced HR and improved functional class and QoL in Chinese patients with chronic HF. Treatment was well tolerated.
Clinical Trial Registration:
ISRCTN11703380; registered on 8 November 2016.
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