UMIN-CTR Clinical Trial

Basic information
Public title	Cancer morbidity in patients with cardiac dysfunction with left ventricular ejection fraction <50%
Acronym	Cancer morbidity in patients with cardiac dysfunction
Scientific Title	Cancer morbidity in patients with cardiac dysfunction with left ventricular ejection fraction <50%
Scientific Title:Acronym	Cancer morbidity in patients with cardiac dysfunction
Region	Japan

Condition
Condition	heart failure
Classification by specialty	Cardiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To identify the cancer morbidity of patients with cardiac dysfunction
Basic objectives2	Others
Basic objectives -Others	Descriptive study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Cancer morbidity of patients with cardiac dysfunction
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	65 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with echocardiographic evidence of left ventricular ejection fraction of 50% or less
Key exclusion criteria	None
Target sample size	3000

Research contact person
Name of lead principal investigator	1st name Shinya Middle name Last name Fujiki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata
TEL	025-227-2185
Email	sfujiki@med.niigata-u.ac.jp

Public contact
Name of contact person	1st name Shinya Middle name Last name Fujiki
Organization	Niigata University Graduate School of Medical and Dental Sciences
Division name	Department of Cardiovascular Biology and Medicine
Zip code	951-8510
Address	1-757 Asahimachidori, Chuo-ku, Niigata
TEL	025-227-2185
Homepage URL
Email	sfujiki@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University
Institute
Department

Funding Source
Organization	None
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	The ethical committees of Niigata University
Address	1-757 Asahimachidori, Chuo-ku, Niigata
Tel	025-227-2625
Email	ethics@adm.niigata-u.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

Other administrative information
Date of disclosure of the study information	2021 Year 02 Month 10 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	2019 Year 06 Month 20 Day
Date of IRB	2019 Year 07 Month 22 Day
Anticipated trial start date	2019 Year 08 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 10 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information	1. Gender, age, past history, comorbidities, medication 2. Date of onset, type of cancer 3. Height, weight, vital signs 4. Blood test 5. 12 Lead ECG 6. Echocardiography

Management information
Registered date	2021 Year 02 Month 10 Day
Last modified on	2022 Year 08 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000049411