UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029928 |
|---|---|
| Receipt number | R000034151 |
| Scientific Title | Early Detection and Pharmacological Intervention for exercise-induced or cold-pressor-induced PH |
| Date of disclosure of the study information | 2017/11/10 |
| Last modified on | 2018/03/30 01:04:46 |
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Basic information
Public title
Early Detection and Pharmacological Intervention for exercise-induced or cold-pressor-induced PH
Acronym
Early intervention for exercise-induced or cold-pressor-induced PH
Scientific Title
Early Detection and Pharmacological Intervention for exercise-induced or cold-pressor-induced PH
Scientific Title:Acronym
Early intervention for exercise-induced or cold-pressor-induced PH
Region
| Japan |
Condition
Condition
exercise-induced pulmonary hypertension, cold-pressor-induced pulmonary hypertension
Classification by specialty
| Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) To elucidate the clinical coarse of exercise-induced pulmonary hypertension (mean pulmonary arterial pressure >30 mmHg during exercise)associated with connective tissue disease
2) To evaluate the efficacy of early pharmacological intervention for exercise-induced pulmonary hypertension associated with connective tissue disease
3) To elucidate the clinical coarse of cold-pressor-induced pulmonary hypertension associated with connective tissue disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change from baseline to year 3 in mean pulmonary arterial pressure at rest
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pharmacological intervention group.
Pulmonary arterial hypertension specific drug
(PDE 5 inhibitor and/or endothelin receptor antagonist) shall be orally administered.
Interventions/Control_2
Non pharmacological intervention group.
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
Male and female adult patients with connective tissue disease who have been diagnosed with Exercise induced pulmonary hypertension.
Confirmed diagnosis of exercise induced pulmonary hypertension with:
- mPAP < 25 mmHg at rest
- mPAP >= 30 mmHg during exercise
Key exclusion criteria
-Received pulmonary arterial hypertension specific therapy
-History of ischemic heart disease
-Severe renal impairment (creatinine clearance <30 ml/min) at Screening
-Severe hepatic impairment (Child-Pugh class C with or without cirrhosis) at Screening
-Uncontrolled hypertension (>=180/110 mmHg) at Screening
-Severe hypotension (<90/50 mmHg) at Screening
-active cancer
-Females who are pregnant or breastfeeding
-Noncompliance with previous medical regimens
-Participated in a clinical study involving another investigational drug
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshito Ogihara |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5015
yoshito@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshito Ogihara |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
2-174, Edobashi, Tsu, Mie
TEL
059-231-5015
Homepage URL
yoshito@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Graduate School of Medicine
Department of Cardiology and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
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
三重大学医学部附属病院(三重県)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 10 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 07 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 11 | Month | 10 | Day |
Last modified on
| 2018 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034151
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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