Clinical Trial of Systolic Heart Failure Treatment of IvabRadine Hemisulfate Sustained-release Tablets (FIRST) (FIRST)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Systolic Heart Failure | Drug: IvabRadine hemisulfate Sustained-release Tablets Drug: placebo | Phase 2 Phase 3 |
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 |

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 |
- Change From Baseline in Left Ventricular End Systolic Volume Index by ultrasound cardiogram [ Time Frame: baseline and week 32 ]
- 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 ]

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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 |
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

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
Contact: Jianan Wang, doctor | 0571-87315001 | wang_jian_an@tom.com |
China, Beijing | |
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Beijing, Beijing, China | |
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The second affiliated hospital of suzhou university | Not yet recruiting |
Suzhou, Jiangsu, China | |
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shengjing hospital of China medical university | Not yet recruiting |
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Qilu Hospital of Shandong University | Not yet recruiting |
Jinan, Shandong, China | |
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the Second Hospital of Shandong University | Not yet recruiting |
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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 |
Principal Investigator: | Jianan Wang, Doctor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
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 |
Heart Failure Heart Failure, Systolic Heart Diseases Cardiovascular Diseases |