UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056935 |
|---|---|
| Receipt number | R000065068 |
| Scientific Title | Safety Evaluation of Ivabradine and Beta Blockers for Acute Heart Failure with Sinus Tachycardia |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/02/04 23:17:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety Evaluation of Ivabradine and Beta Blockers for Acute Heart Failure with Sinus Tachycardia
Acronym
Safety Evaluation of Ivabradine and Beta Blockers for Acute Heart Failure with Sinus Tachycardia
Scientific Title
Safety Evaluation of Ivabradine and Beta Blockers for Acute Heart Failure with Sinus Tachycardia
Scientific Title:Acronym
Safety Evaluation of Ivabradine and Beta Blockers for Acute Heart Failure with Sinus Tachycardia
Region
| Japan |
Condition
Condition
HFrEF patients
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
we aim to evaluate the safety of ivabradine by comparing its use with beta-blockers in patients with acute HFrEF and sinus tachycardia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint was heart failure exacerbation events within one year, divided into beta-blocker and ivabradine treatment groups introduced at the first outpatient visit as a safety outcome.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
This retrospective study collected data on HFrEF patients with the first apparent heart failure treated as outpatients at three centers between 2019 and 2023. Heart failure was defined in this study according to criteria established in the guidelines of the Japanese Society of Cardiology. The enrollment criteria for the study stipulated that patients fulfilling the following conditions were eligible for inclusion:
NT-pro BNP level of > 1000 pg/mL at the first outpatient visit
New York Heart Association (NYHA) classification 2 or 3 degree
Sinus tachycardia at the first outpatient visit
Use of beta-blockers or ivabradine at the first visit
LVEF < 40%
Key exclusion criteria
Exclusion criteria were ischemic heart disease, moderate or severe primary valve failure, and dialysis.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Nasu |
Organization
Iwate Medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
tnasu@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Takahito |
| Middle name | |
| Last name | Nasu |
Organization
Iwate medical University
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
TEL
019-613-7111
Homepage URL
tnasu@iwate-med.ac.jp
Sponsor or person
Institute
Iwate medical university
Institute
Department
Personal name
Funding Source
Organization
Iwate medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Iwate medical university
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tel
019-613-7111
tnasu@iwate-med.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
岩手医科大学(岩手)、岩手県立久慈病院(岩手)、岩手県立大船渡病院(岩手)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1Age, 2Gender, 3Height, 4Weight, 5Information on medical history, 6Vital signs, test data, and drug data at the first medical examination, 7Vital signs, test data, and drug data after 1 month, 3 months, and 1 year,8Outcome
Management information
Registered date
| 2025 | Year | 02 | Month | 04 | Day |
Last modified on
| 2025 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065068
