UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006314 |
|---|---|
| Receipt number | R000007480 |
| Scientific Title | The Effects of Vasodilators agents on Right Ventricular Energetics in patients with Pulmonary Hypertension: A study using Carbon-11 Acetate PET, oxygen-15 labeled water PET, and biomarkers |
| Date of disclosure of the study information | 2011/09/10 |
| Last modified on | 2011/09/08 16:20:18 |
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Basic information
Public title
The Effects of Vasodilators agents on Right Ventricular Energetics in patients with Pulmonary Hypertension:
A study using Carbon-11 Acetate PET, oxygen-15 labeled water PET, and biomarkers
Acronym
Effects of Vasodilator agents on Right Ventricular Energetics in patients with Pulmonary arterial Hypertension (RIVER study)
Scientific Title
The Effects of Vasodilators agents on Right Ventricular Energetics in patients with Pulmonary Hypertension:
A study using Carbon-11 Acetate PET, oxygen-15 labeled water PET, and biomarkers
Scientific Title:Acronym
Effects of Vasodilator agents on Right Ventricular Energetics in patients with Pulmonary arterial Hypertension (RIVER study)
Region
| Japan |
Condition
Condition
Pulmonary arterial hypertension
Classification by specialty
| Cardiology | Pneumology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. The first aim of this study is to compare the right ventricular cardiac metabolism and efficiency, vascular resistance with normal controls.
2. The second aim of this study is to evaluate the chronic therapeutic effects of vasodilators such as endothelin antagonists, phosphodiesterase-5 inhibitors, prostanoids, or their combination on right ventricular cardiac metabolism and efficiency using carbon-11 dynamic positron emission tomography.
3. The third aim of this study is to compare the right ventricular cardiac metabolism and efficiency, vascular resistance with other PH specific clinical parameters including right ventricular catheter measurements, exercise capacity, other imaging modalities, and biomarkers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
WHO functional class, 6-minute walk.
Positron emission tomography: 11C acetate PET for evaluating myocardial oxidative metabolism and efficiency.
15O labeled water for evaluating myocardial blood flow and coronary resistance.
Right heart catheterization for evaluating pulmonary arterial pressure and pulmonary arterial resistance.
Echocardioghraphy, cardiac magnetic resonance imaging, ECG, and biomarkers from blood samples.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
We will look at the effects of vasodilators such as endothelin antagonists, phosphodiesterase-5 inhibitors, or their combination on pulmonary hypertension and myocardial oxidative metabolism.
PH patients will be divided into 3 groups such as new treatment group, no vasodilator treatment group, and already have vasodilators without changing treatment regime.
We will evaluate the therapeutic response 3 months after the treatment.
Interventions/Control_2
no vasodilator treatment group
Interventions/Control_3
already have vasodilators without changing treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with symptomatic pulmonary hypertension (WHO functional class II to IV) despite treatment with anticoagulant drugs, vasodilators, diuretic or supplemental oxygen.
Pulmonary artery hypertension will be either primary, chronic peripheral pulmonary artery thrombosis, or associated with connective-tissue disease.
Age less than 20 when their guardian agrees with the entry.
Key exclusion criteria
Patients with coronary artery disease
life expectancy less than 1 year due to other co-morbidity
paced rhythm
Prior diagnostic sleep related disorder.
inability to obtain informed consent
pregnant or breast-feeding
claustrophobia
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiichiro Yoshinaga, M.D., Ph.D, F.A.C.C.. |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Photobiology
Zip code
Address
Kita-15, Nishi-7, Kita-Ku, Sapporo
TEL
011-706-5152
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiichiro Yoshinaga, M.D., Ph.D, F.A.C.C.. |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Photobiology
Zip code
Address
Kita-15, Nishi-7, Kita-Ku, Sapporo
TEL
011-706-5152
Homepage URL
kyoshi@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
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
北海道大学病院（北海道）
Hokkaido University Hospital(Hokkaido)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2010 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 09 | Month | 08 | Day |
Last modified on
| 2011 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007480
