Status:
UNKNOWN
Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Chronic Systolic Heart Failure
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
PHASE3
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 hemisul...
Eligibility Criteria
Inclusion
- aged from 18 to 75 years, males or females
- Willing to provide written informed consent
- NYHA Class II, III, or IV for≥4 weeks, in stable clinical condition for
- ≥4 weeks
- Optimized and unchanged chronic heart failure medications and dosages for≥4 weeks
- Sinus rhythm with resting heart rate≥70 b.p.m.
- Left-ventricular systolic dysfunction, with ejection fraction≥40% documented within previous 1 month
Exclusion
- Unstable cardiovascular condition(for example, hospital admission for worsening heart failure)
- Recent (\<2 months) myocardial infarction or recent or scheduled coronary revascularization
- Stroke or transient cerebral ischaemia within previous 4 weeks
- Severe primary valvular disease
- Scheduled surgery of valvular heart disease
- Active myocarditis
- Congenital heart diseases
- peripartum cardiomyopathy
- hyperthyroid heart disease
- On list for cardiac transplantation
- Cardiac resynchronization therapy started within previous 6 months
- Pacemaker with atrial or ventricular pacing (except biventricular pacing)˃40% of the time, or with stimulation threshold at the atrial or ventricular level˃60 b.p.m.
- Permanent atrial fibrillation or flutter
- Sick sinus syndrome, sinoatrial block, second and third degree atrio-ventricular block
- History of symptomatic or sustained (≥30 s) ventricular arrhythmia unless a cardioverter/defibrillator implanted
- Cardioverter/defibrillator shock within previous 6 months
- Family history or congenital long QT syndrome or treated with selected QT-prolonging products(except amiodarone)
- Contraindication or intolerance to ivabradine or lactulose
- Severe or uncontrolled hypertension (SBP≥180 mmHg or DBP≥110 mmHg)
- known anaemia(Hb\<100 g/L)
- Known moderate or severe liver disease(ALT/AST˃3ULN), known severe renal disease(Cr˃2ULN)
- Pregnant or lactating women and women planning to become pregnant
- Use of an investigational drug within 30 days of enrollment
- Has a history of psychological illness/condition that interferes with ability to understand or complete requirements of the study
Key Trial Info
Start Date :
May 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT02188082
Start Date
May 1 2014
Last Update
July 11 2014
Active Locations (12)
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1
The military general hospitla of Beijing PLA
Beijing, Beijing Municipality, China
2
The second affiliated hospital of suzhou university
Suzhou, Jiangsu, China
3
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, China, 225001
4
the First Hospital of Jilin University
Changchun, Jilin, China