UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029862 |
|---|---|
| Receipt number | 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 | 2023/05/13 22:24:31 |
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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 | Shohei |
| Middle name | |
| Last name | Kikuchi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Cardiology
Zip code
4678602
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Aichi, Japan
TEL
052-853-8221
syohey@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Kikuchi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Cardiology
Zip code
4678602
Address
1-Kawasumi, Mizuho-cho, Mizuho-ku Nagoya, Aichi, Japan
TEL
052-853-8221
Homepage URL
syohey@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
IRB of Nagoya City Rehabilitation and Sports Center Hospital
Address
1-2, Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-835-3811
soumubu@nagoya-rehab.or.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
| 2018 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
No URL
Publication of results
Unpublished
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
27
Results
HED-Late was significantly lower in HFpEF compared to the control group of healthy subjects without cardiovascular complications and hypertensive patients (healthy subjects: 9.2 4.8 vs. hypertensive patients: 15.8 2.5 vs. HFpEF: 12.4 3.1(%/min), p=0.005).
Results date posted
| 2021 | Year | 11 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Thirteen patients with HFpEF in compensated state, 7 patients with hypertension, and 7 healthy controls were enrolled in the study.
Participant flow
After obtaining consent to participate in the study,
PET scan was performed: C11-labeled hydroxyephedrine (HED) was administered, and imaging was performed using a Siemens device for 40 minutes.
Blood tests and echocardiography were performed on the same day.
PET images were analyzed using PMOD.
Adverse events
Nothing
Outcome measures
We calculated the global retention index (HED-RI) by dividing the myocardial tracer activity between 30-40 minutes by the integral of the activity input (HED-Late).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Nothig
Management information
Registered date
| 2017 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033807
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/11/13 | リハセン新申請書-R2（HED-HFpEF）.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
