UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029862
Receipt No. R000033807
Scientific Title Quantification of presynaptic cardiac sympathetic function with Carbon-11-Hydroxyephedrine positron emission tomography in patients with heart failure with preserved ejection fraction
Date of disclosure of the study information 2018/01/01
Last modified on 2018/03/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Quantification of presynaptic cardiac sympathetic function with Carbon-11-Hydroxyephedrine positron emission tomography in patients with heart failure with preserved ejection fraction
Acronym Quantification of presynaptic cardiac sympathetic function in patients with HFpEF
Scientific Title Quantification of presynaptic cardiac sympathetic function with Carbon-11-Hydroxyephedrine positron emission tomography in patients with heart failure with preserved ejection fraction
Scientific Title:Acronym Quantification of presynaptic cardiac sympathetic function in patients with HFpEF
Region
Japan

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

Objectives
Narrative objectives1 To evaluate cardiac presynaptic sympathetic nervous activity in patients with heart failure with preserved ejection fraction using PET.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between cardiac presynaptic sympathetic nervous activity and cardiac function, as well as severity of heart failure.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Perfusion scan using 13N-NH3 was combined with HED dynamic PET.
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1
Key exclusion criteria 1
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kikuchi Shohei
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Cardio-Renal Medicine and Hypertension
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Aichi, Japan
TEL 052-853-8221
Email syohey@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kikuchi Shohei
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Cardio-Renal Medicine and Hypertension
Zip code
Address 1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Aichi, Japan
TEL 052-853-8221
Homepage URL
Email syohey@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Nagoya City Rehabilitation and Sports Center Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 01 Month 01 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
2017 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 07 Day
Last modified on
2018 Year 03 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033807

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.