UMIN-CTR Clinical Trial

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
Email	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
Email	nishikohri@ono.co.jp

Sponsor
Institute	Ono Pharmaceutical Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049651