UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000009386
Receipt No. R000010974
Scientific Title Comprehensive risk assessment by cardiac MRI and PET in patients with diastolic heart failure
Date of disclosure of the study information 2012/11/22
Last modified on 2019/10/29 (Ver. 7)

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Basic information
Public title Comprehensive risk assessment by cardiac MRI and PET in patients with diastolic heart failure
Acronym Comprehensive risk assessment by cardiac MRI and PET
Scientific Title Comprehensive risk assessment by cardiac MRI and PET in patients with diastolic heart failure
Scientific Title:Acronym Comprehensive risk assessment by cardiac MRI and PET
Region
Japan

Condition
Condition Chronic heart failure with LVEF more than and equal 40%
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1) To develop the model for the evaluation of cardiac risk by using cardiac MRI-meausred diastolic function, coronary flow reserve, and scar, and PET-measured sympathetic function.
2) to evaluate the mechanism of diastolic dysfunctio and to develop the effective therapy for each patient.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. patient's characteristics
2. Symptom
3. Patient's history
4. Cardiac history
5. History of heart failure
6. Clinical variables
7. Echocardiography
8. Cardiac MRI
9. Cardiac PET
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients
1. Age more than and equal 20 yo.
2. Chronic heart failure diagnosed by Framingham criteria
3. LVEF more than and equal 40%
4. Patients who agree with informed consent
Healty controls
1. Age more than and equal 20yo.
2. No heart failure symptom
3. Subjects who agree with informed consent
Key exclusion criteria Patients
1. Chronic kidney disease (eGFR<30 mL/min2)
2. Claustrophobia
Healty controls
1. Chronic kidney disease (eGFR<30 mL/min2)
2. Claustrophobia
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Tsutsui
Organization Hokkaido University Guraduate School of Medicine
Division name Cardiovasculer Medicine
Zip code 060-8638
Address kita 15 jyo, nisi 7 chome ,kitaku,Sapporo,Hokkaido
TEL 011-706-6073
Email naya@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Masanao
Middle name
Last name Naya
Organization Hokkaido University Guraduate School of Medicine
Division name Cardiovasculer Medicine
Zip code 060-8638
Address Kitty 15, West 7, Kitaku, Sapporo
TEL 011-706-6973
Homepage URL
Email nayamasanao@yahoo.co.jp

Sponsor
Institute Hokkaido University Guraduate School of Medicine
Institute
Department

Funding Source
Organization KAKEN
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital
Address North 15, West 5, Kitaku, Sapporo
Tel 011-706-7636
Email crjimu@huhp.hokudai.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
2012 Year 11 Month 22 Day

Related information
URL releasing protocol noe
Publication of results Published

Result
URL related to results and publications J Nucl Med. 2017 May;58(5):784-790. doi: 10.2967/jnumed.116.178558.
Number of participants that the trial has enrolled 53
Results 
Please see a paper above
Results date posted
2019 Year 10 Month 29 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Please see a paper above
Participant flow 
Please see a paper above
Adverse events 
none
Outcome measures 
Please see a paper above
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 11 Month 13 Day
Date of IRB
2012 Year 10 Month 09 Day
Anticipated trial start date
2012 Year 11 Month 22 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective cohort study

Management information
Registered date
2012 Year 11 Month 22 Day
Last modified on
2019 Year 10 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010974