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Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST） (FIRST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188082
Recruitment Status : Unknown
Verified May 2014 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Systolic Heart Failure Drug: IvabRadine hemisulfate Sustained-release Tablets Drug: placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets （FIRST）
Study Start Date : May 2014
Estimated Primary Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
Drug Information available for: Ivabradine

Arms and Interventions
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Arm Intervention/treatment
Experimental: IvabRadine hemisulfate Sustained-release Tablets
5-15mg qd
 Drug: IvabRadine hemisulfate Sustained-release Tablets
Placebo Comparator: placebo
5-15mg qd
 Drug: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram [ Time Frame: baseline and week 32 ]

Secondary Outcome Measures :
  1. Change From Baseline in Left Ventricular End Diastolic Volume Index and left ventricular ejection fraction(LVEF) [ Time Frame: baseline and week 32 ]
  2. incidence of hospital admission for worsening heart failure、any cardiovascular hospital admission、 cardiovascular mortality、all-cause mortality [ Time Frame: baseline and week 32 ]
  3. change from baseline in distance of 6-minute walking test [ Time Frame: baseline and week 32 ]
  4. change from baseline in heart rate [ Time Frame: baseline and week 32 ]
  5. change from baseline in scores of Kansas City Cardiomyopathy Questionnaire [ Time Frame: baseline and week 32 ]
  6. change from baseline in NT-proBNP [ Time Frame: baseline and week 32 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188082


Contacts
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Contact: Jianan Wang, doctor 0571-87315001 wang_jian_an@tom.com

Locations
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China, Beijing
The military general hospitla of Beijing PLA Not yet recruiting
Beijing, Beijing, China
Contact: Junxia Li         
Sub-Investigator: Junxia Li         
China, Jiangsu
The second affiliated hospital of suzhou university Not yet recruiting
Suzhou, Jiangsu, China
Contact: Yang Jiao         
Sub-Investigator: Yang Jiao         
Subei People's Hospital of Jiangsu province Not yet recruiting
Yangzhou, Jiangsu, China, 225001
Contact: Xiang Gu         
Sub-Investigator: Xiang Gu         
China, Jilin
the First Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China
Contact: Yu Zhang         
Sub-Investigator: Yu Zhang         
China, Liaoning
shengjing hospital of China medical university Not yet recruiting
Shenyang, Liaoning, China
Contact: Shumei Ma         
Sub-Investigator: Shumei Ma         
China, Shandong
Qilu Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China
Contact: Ming Zhong         
Sub-Investigator: Ming Zhong         
the Second Hospital of Shandong University Not yet recruiting
Jinan, Shandong, China
Contact: Qinghua Lu         
Sub-Investigator: Qinghu Lu         
China, Zhejiang
The first affiliated hospital of zhejiang university school of medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310003
Contact: Xiaosheng Hu         
Sub-Investigator: Xiaosheng Hu         
Hangzhou First People'S Hospital Not yet recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Yizhou Xu         
Sub-Investigator: Yizhou Xu         
The second affiliated hospital of zhejiang university school of medicine Recruiting
Hangzhou, Zhejiang, China, 310009
Contact: Jianan Wang, doctor         
Principal Investigator: Jianan Wang, doctor         
The first affiliated hospital of wenzhou medical university Not yet recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Weijian Huang         
Sub-Investigator: Weijian Huang         
The second affiliated hospital of wenzhou medical university Not yet recruiting
Wenzhou, Zhejiang, China
Contact: Jifei Tang         
Sub-Investigator: Jifei Tang         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Jianan Wang, Doctor Second Affiliated Hospital, School of Medicine, Zhejiang University
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT02188082    
Other Study ID Numbers: LSQYFBLDHF2013
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Heart Failure
Heart Failure, Systolic
Heart Diseases
Cardiovascular Diseases