Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
FIRST
1 other identifier
interventional
336
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 9, 2014
CompletedFirst Posted
Study publicly available on registry
July 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedJuly 11, 2014
May 1, 2014
3.3 years
July 9, 2014
July 10, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram
baseline and week 32
Secondary Outcomes (6)
Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF)
baseline and week 32
incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality
baseline and week 32
change from baseline in distance of 6-minute walking test
baseline and week 32
change from baseline in heart rate
baseline and week 32
change from baseline in scores of Kansas City Cardiomyopathy Questionnaire
baseline and week 32
- +1 more secondary outcomes
Study Arms (2)
IvabRadine hemisulfate Sustained-release Tablets
EXPERIMENTAL5-15mg qd
placebo
PLACEBO COMPARATOR5-15mg qd
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
The military general hospitla of Beijing PLA
Beijing, Beijing Municipality, China
The second affiliated hospital of suzhou university
Suzhou, Jiangsu, China
Subei People's Hospital of Jiangsu province
Yangzhou, Jiangsu, 225001, China
the First Hospital of Jilin University
Changchun, Jilin, China
shengjing hospital of China medical university
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
the Second Hospital of Shandong University
Jinan, Shandong, China
The first affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310003, China
Hangzhou First People'S Hospital
Hangzhou, Zhejiang, 310006, China
The second affiliated hospital of zhejiang university school of medicine
Hangzhou, Zhejiang, 310009, China
The first affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, 325000, China
The second affiliated hospital of wenzhou medical university
Wenzhou, Zhejiang, China
Related Publications (1)
Ye F, Wang X, Wu S, Ma S, Zhang Y, Liu G, Liu K, Yang Z, Pang X, Xue L, Lu S, Zhong M, Li J, Yu H, Lou D, Cui D, Xie X, Wang J; FIRST Investigators. Sustained-Release Ivabradine Hemisulfate in Patients With Systolic Heart Failure. J Am Coll Cardiol. 2022 Aug 9;80(6):584-594. doi: 10.1016/j.jacc.2022.05.027.
PMID: 35926931DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Jianan Wang, Doctor
Second Affiliated Hospital, School of Medicine, Zhejiang University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2014
First Posted
July 11, 2014
Study Start
May 1, 2014
Primary Completion
August 1, 2017
Last Updated
July 11, 2014
Record last verified: 2014-05