UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study to identify the prevalence of osteoporosis in patients with heart failure
Acronym	The prevalence of osteoporosis in patients with heart failure
Scientific Title	Prospective observational study to identify the prevalence of osteoporosis in patients with heart failure
Scientific Title:Acronym	The prevalence of osteoporosis in patients with heart failure
Region	Japan

Condition
Condition	Chronic heart failure
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify the prevalence and characteristics of osteoporosis in elderly patients with heart failure
Basic objectives2	Others
Basic objectives -Others	Descriptive study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The prevalence and characteristics of osteoporosis in elderly patients with heart failure
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	1.Stage B and C heart failure 2.over 65 years
Key exclusion criteria	None
Target sample size	300

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	Japan Osteoporosis Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
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 05 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	2020 Year 08 Month 03 Day
Date of IRB	2020 Year 11 Month 13 Day
Anticipated trial start date	2021 Year 01 Month 06 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1. Gender, age, past history, comorbidities, medication 2. Kihon checklist, NYHA 3. Height, weight, vital signs 4. Blood test 5. 12 Lead ECG 6. Echocardiography 7. FRAX 8. Dual Energy X-ray Absorption 9. Spine radiograph

Management information
Registered date	2021 Year 02 Month 05 Day
Last modified on	2021 Year 08 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049373