UMIN-CTR Clinical Trial

Basic information
Public title	Underlying mechanisms associated with long-term prognosis between patients with new-onset heart failure and worsening of chronic hart failure
Acronym	KINDAI-HF Registry
Scientific Title	Underlying mechanisms associated with long-term prognosis between patients with new-onset heart failure and worsening of chronic hart failure
Scientific Title:Acronym	KINDAI-HF Registry
Region	Japan

Condition
Condition	Heart Failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Patients with worsening o chronic Heart failure have worse prognosis compared to those with new-onset heart failure. The aim of this prospective cohort study is to clarify difference of underlying mechanisms associated with prognosis between patients with new-onset heart failure and worsening of chronic heart failure.
Basic objectives2	Others
Basic objectives -Others	To clarify underlying mechanisms associated with prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of composite endpoint between patients with new-onset heart failure and worsening of chronic heart failure
Key secondary outcomes	Clinical factors associated with long-term prognosis between patients with new-onset heart failure and worsening of chronic heart failure

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	Patients hospitalized with acute heart failure
Key exclusion criteria	Not obtained informed consent
Target sample size	700

Research contact person
Name of lead principal investigator	1st name Koichiro Middle name Koichiro Last name Matsumura
Organization	Kindai University
Division name	Department of Cardiology
Zip code	5898511
Address	377-2, Ohnohigashi, Osakasayama
TEL	+81723660221
Email	kmatsumura1980@yahoo.co.jp

Public contact
Name of contact person	1st name Koichiro Middle name Last name Matsumura
Organization	Kindai University
Division name	Department of Cardiology
Zip code	5898511
Address	377-2, Ohnohigashi, Osakasayama
TEL	+81723660221
Homepage URL
Email	kmatsumura1980@yahoo.co.jp

Sponsor
Institute	Kindai University
Institute
Department

Funding Source
Organization	Kindai University
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	Department of Cardiology, Kindai University
Address	377-2, Ohnohigashi, Osakasayama
Tel	+81723660221
Email	kmatsumura1980@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	2021 Year 07 Month 13 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	Open public recruiting
Date of protocol fixation	2021 Year 07 Month 13 Day
Date of IRB	2021 Year 07 Month 13 Day
Anticipated trial start date	2021 Year 07 Month 13 Day
Last follow-up date	2026 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Study design: Prospective cohort study Participants: Patients hospitalized with acute decompensated heart failure Observation: Background information Vital sign at admission and at discharge Laboratory test, echocardiography, medication including furosemide at admission and at discharge at admission and at discharge Sarcopenia test (grip strength, short physical performance battery, appendicular skeletal muscle mass by bio impedance analysis) Calf circumference Tongue pressure Biomarker (BDNF; brain-derived neurotrophic factor) Primary outcome: Composite endpoint including all-cause death and heart failure rehospitalization Secondary outcome: In-hospital death All-cause death Cardiac death Heart failure rehospitalization

Management information
Registered date	2021 Year 07 Month 13 Day
Last modified on	2022 Year 02 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051234