UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043495 |
|---|---|
| Receipt number | R000049651 |
| Scientific Title | Identification of predictive factors interacting with heart rate reduction therapy for potential clinical benefit in chronic heart failure: a systematic literature review and meta-analysis |
| Date of disclosure of the study information | 2021/03/02 |
| Last modified on | 2022/12/09 15:38:36 |
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Basic information
Public title
Identification of predictive factors interacting with heart rate reduction therapy for potential clinical benefit in chronic heart failure: a systematic literature review and meta-analysis
Acronym
Factors that interact with heart rate reduction in chronic heart failure
Scientific Title
Identification of predictive factors interacting with heart rate reduction therapy for potential clinical benefit in chronic heart failure: a systematic literature review and meta-analysis
Scientific Title:Acronym
Factors that interact with heart rate reduction in chronic heart failure
Region
| Japan |
Condition
Condition
chronic heart failure
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate HR-reducing strategies, based on baseline HR, underlying diseases, causes and complications of chronic HFrEF, and various patient characteristics.
Basic objectives2
Others
Basic objectives -Others
To investigate the evidence of beneficial clinical outcomes based on the interaction of predictive factors with reduction of HR in chronic heart failure patients with reduced ejection fraction (HFrEF).
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary: To measure the relative contributions of predictive factors on the effect of HR reduction on clinical outcomes in the context of HFrEF.
Key secondary outcomes
Secondary: To show the strength of the interactions between HR reduction and predictive factors and their effect on clinical outcomes.
Secondary: To measure the relative contributions of predictive factors on the effect of treatment on clinical outcomes in subgroups that have had their HR reduced by >=10 bpm or <10 bpm.
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Study-level inclusion criteria: studies that were randomized and placebo-controlled clinical trials; studies published in English; studies with full text available; studies investigating the effect of HR reducing therapies on change in HR and/or other clinical outcomes; and studies published between database inception and December 2020. Patient-level inclusion criteria: patient population of adults aged >=18 years; and patient population with symptomatic chronic HF.
Key exclusion criteria
Case-control studies; observational studies; studies involving adults <18 years; studies not investigating HR-reducing therapy; studies with no quantitative data or measurable outcomes; studies with incomplete or qualitative data alone; and reviews and collections of conference abstracts
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Futoshi |
| Middle name | |
| Last name | Kinoshita |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
541-8564
Address
8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL
06-6263-2992
f.kinoshita@ono.co.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Nishikori |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Medical Affairs
Zip code
541-8564
Address
8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
TEL
06-6263-2992
Homepage URL
nishikohri@ono.co.jp
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
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
Ono Pharmaceutical Co., Ltd.
Address
8-2, Kyutaromachi 1-Chome, Chuo-ku, Osaka-Shi, Osaka, Japan
Tel
06-6263-2992
n.nishiwaki@ono.co.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 | 03 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S2352906722001907
Number of participants that the trial has enrolled
0
Results
This meta-analysis revealed that T2DM is a predictor of HR-reducing treatment effect on all-cause mortality and CV-related mortality in HFrEF patients.
Results date posted
| 2022 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
To measure the relative contributionsof predictive factors on the effect of HR reduction on clinical outcomes in the context of HFrEF.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The specific objectives of this systematic review and meta-analysis are in relation to investigating the impact of HR-reducing strategies based on baseline HR, underlying diseases, causes and complications of chronic HFrEF, and various patient-related characteristics
-Primary: To measure the relative contributions of predictive factors on the effect of HR-reducing treatment on all cause mortality and other clinical outcomes in chronic HFrEF
-Secondary: To show the strength of interactions between HR reduction and predictive factors and their effect on all-cause mortality and other clinical outcomes as feasible
-Secondary: To measure the relative contributions of predictive factors on the effect of treatment on all cause mortality in subgroups that have had their HR reduced by >=10 or <10 bpm
This study uses a systematic literature review and meta-analysis.Therefore, this study does not require approval by IRB.
Management information
Registered date
| 2021 | Year | 03 | Month | 02 | Day |
Last modified on
| 2022 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049651
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