UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045871 |
|---|---|
| Receipt number | R000052367 |
| Scientific Title | Safety and Efficacy of Ivabradine Hydrochloride in Hemodialysis Patients with Chronic Heart Failure |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2023/06/08 14:23:52 |
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Basic information
Public title
Safety and Efficacy of Ivabradine Hydrochloride in Hemodialysis Patients with Chronic Heart Failure
Acronym
Safety and Efficacy of Ivabradine Hydrochloride in Hemodialysis Patients with Chronic Heart Failure
Scientific Title
Safety and Efficacy of Ivabradine Hydrochloride in Hemodialysis Patients with Chronic Heart Failure
Scientific Title:Acronym
Safety and Efficacy of Ivabradine Hydrochloride in Hemodialysis Patients with Chronic Heart Failure
Region
| Japan |
Condition
Condition
Hemodialysis patients with chronic heart failure whose resting heart rate is 75 beats per minute or higher
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy of ivabradine hydrochloride administration in hemodialysis patients with chronic heart failure whose resting heart rate is 75 beats per minute or higher.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in resting heart rate from baseline to 12 weeks post-dose
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ivabradine hydrochloride
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. patients with chronic heart failure in sinus rhythm and a resting heart rate of 75 beats per minute or greater at the time of consent
2. patients receiving standard therapy for chronic heart failure including beta-blockers at the time of consent (including beta-blocker intolerant patients)
3. male or female, 20 years of age or older at the time of consent
4. patients undergoing hemodialysis for more than 12 weeks at the time of consent.
5. patients who have given their written consent to participate in the study.
Key exclusion criteria
1. patients with a history of hypersensitivity to any component of ivabradine hydrochloride
2. patients with unstable or acute heart failure
3. patients with cardiogenic shock
4. patients with severe hypotension (systolic blood pressure less than 90 mmHg or diastolic blood pressure less than 50 mmHg)
5. patients with atrial fibrillation
6. patients with sinus failure syndrome, sinoatrial block, or third degree atrioventricular block 7. patients with severe hepatic dysfunction
7) Patients with severe hepatic dysfunction (Child-Pugh C)
8. patients receiving the following drugs: ritonavir-containing products, josamycin, itraconazole, clarithromycin, cobicistat-containing products, indinavir, voriconazole, nelfinavir, saquinavir, telaprevir
9. patients who are pregnant, lactating, may be pregnant or plan to become pregnant
10. patients who are receiving verapamil or diltiazem
11. patients who are scheduled to undergo surgical treatment during the study period 12.
12. patients who require a substitute.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yukinao |
| Middle name | |
| Last name | Sakai |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
y-sakai@nms.ac.jp
Public contact
Name of contact person
| 1st name | Sayuri |
| Middle name | |
| Last name | Kawasaki |
Organization
Nippon Medical School
Division name
Department of Nephrology
Zip code
113-8603
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
TEL
03-3822-2131
Homepage URL
k-sayuri@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital Center for Clinical Research
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo
Tel
03-3822-2131
clinicaltrial@nms.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 26 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052367
