UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic significance of circulating leukocyte subtype counts in patients with chronic heart failure
Acronym	Prognosis of chronic heart failure and monocyte
Scientific Title	Prognostic significance of circulating leukocyte subtype counts in patients with chronic heart failure
Scientific Title:Acronym	Prognosis of chronic heart failure and monocyte
Region	Japan

Condition
Condition	Patients of chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Inflammation, characterized by early leukocyte recruitment, is known to be associated with various cardiovascular diseases. We previously reported that a high monocyte count was an independent and incremental of cardiovascular events in patients with coronary artery disease. Furthermore, previous study also reported that inflammation play a crucial role in the pathophysiology of heart failure (HF). Few studies have evaluated the prognostic role of monocyte in patients with HF, and have compared them among categories of HF. To elucidate the prognostic value of monocyte in HF, we investigated the association of monocyte counts in patients with HF with their future cardiovascular events, and compared them between in HF with reduced ejection fraction (HFrEF) and HF with preserved EF (HFpEF)
Basic objectives2	Others
Basic objectives -Others	Inflammation, characterized by early leukocyte recruitment, is known to be associated with various cardiovascular diseases. We previously reported that a high monocyte count was an independent and incremental of cardiovascular events in patients with coronary artery disease. Furthermore, previous study also reported that inflammation play a crucial role in the pathophysiology of heart failure (HF). Few studies have evaluated the prognostic role of monocyte in patients with HF, and have compared them among categories of HF. To elucidate the prognostic value of monocyte in HF, we investigated the association of monocyte counts in patients with HF with their future cardiovascular events, and compared them between in HF with reduced ejection fraction (HFrEF) and HF with preserved EF (HFpEF)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Consecutive HF patients referred for hospitalization at Kumamoto University Hospital between 2006 and 2015 were registered. Finally, a total of 678 HF patients were enrolled in the study, and We further divided HF patients into two types according to HFrEF and HFpEF. We were followed prospectively until 2016 or until the occurrence of HF related events.
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Consecutive HF patients referred for hospitalization at Kumamoto University Hospital between 2006 and 2015 were registered.
Key exclusion criteria	Patients were excluded for the following reasons: severe valvular disease, active infective diseases, history of malignancy, and end stage of renal disease (estimated glomerular filtration rate (eGFR) < 15 ml/min/1.73m).
Target sample size	650

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Tsujita
Organization	Kumamoto univercity hospital
Division name	cardiology
Zip code	860-8556
Address	1-1-1 Honjo Tyuouku Kumamotoshi
TEL	0963735175
Email	tsujita@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Masafumi Middle name Last name Takae
Organization	Kumamoto univercity hospital
Division name	cardiology
Zip code	860-8556
Address	1-1-1 Honjo Tyuouku Kumamotoshi
TEL	0963735175
Homepage URL
Email	qqcv2t3d@yahoo.co.jp

Sponsor
Institute	Kumamoto univercity hospital
Institute
Department

Funding Source
Organization	Kumamoto univercity hospital
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	Kumamoto univercity hospital
Address	1-1-1 Honjo Tyuouku Kumamotoshi
Tel	0963735175
Email	qqcv2t3d@yahoo.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	2019 Year 12 Month 15 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	678
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	2006 Year 04 Month 01 Day
Date of IRB	2017 Year 04 Month 01 Day
Anticipated trial start date	2006 Year 04 Month 01 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2019 Year 12 Month 03 Day
Last modified on	2019 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044203