Clinical Trial: Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
Brief Summary: Ivabradine acts by inhibiting the ionic If current that modulates the pacemaker activity of sinoatrial node cells. The aim of present study is to evaluate the efficacy and safety of IvabRadine hemisulfate Sustained-release Tablets versus placebo in patients with moderate to severe chronic systolic heart failure.
Detailed Summary:
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Current Primary Outcome: Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram [ Time Frame: baseline and week 32 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF) [ Time Frame: baseline and week 32 ]
- incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality [ Time Frame: baseline and week 32 ]
- change from baseline in distance of 6-minute walking test [ Time Frame: baseline and week 32 ]
- change from baseline in heart rate [ Time Frame: baseline and week 32 ]
- change from baseline in scores of Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline and week 32 ]
- change from baseline in NT-proBNP [ Time Frame: baseline and week 32 ]
Original Secondary Outcome: Same as current
Information By: Jiangsu HengRui Medicine Co., Ltd.
Dates:
Date Received: July 9, 2014
Date Started: May 2014
Date Completion:
Last Updated: July 10, 2014
Last Verified: May 2014
