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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006314
Receipt No. 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

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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
Email

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
Email kyoshi@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007480

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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