- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00173537
Genetic Research of Bone Morphogenetic Protein Receptor-II Gene in Taiwanese Patient With Primary Pulmonary Hypertension
December 26, 2012 updated by: National Taiwan University Hospital
Primary pulmonary hypertension (PPH) is a rare lung disorder in which the blood pressure in the pulmonary artery rises far above normal levels for no apparent reason.
The pulmonary artery is a blood vessel carrying oxygen-poor blood from the right ventricle (one of the heart's pumping chambers) to the lungs.
In the lungs, the blood picks up oxygen, then flows to the heart's left side, where the left ventricle pumps it to the rest of the body through the aorta.
In the United States, an estimated 500 to 1,000 new cases of primary pulmonary hypertension are diagnosed each year.
The greatest number is reported in women between ages 20 and 40.
However, men and women in all age ranges as well as very young children can develop PPH.
Researchers have identified more than 40 BMPR2 mutations that can cause primary pulmonary hypertension.
Many of these mutations introduce a stop signal that halts protein production prematurely, decreasing the amount of functional BMPR2 protein.
Other mutations prevent the BMPR2 protein from reaching the cell surface, or alter its structure so it cannot form a complex with other proteins.
It remains unclear how BMPR2 mutations cause primary pulmonary hypertension.
Researchers suggest that a mutation in this gene prevents cell death or promotes cell proliferation, resulting in an overgrowth of cells in the blood vessels of the lungs.
Cell overgrowth can narrow the diameter of the vessels, restricting blood flow and resulting in elevated blood pressure.
However, it has not yet been reported regarding the genetic variants in Taiwan.
Further details have been described in this project proposal.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
1
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 10002
- Recruiting
- National Taiwan University Hospital
-
Contact:
- Haso-Hsun Hsu, physician
- Phone Number: 5913 886-2-23123456
- Email: ntuhfred@yahoo.com.tw
-
Principal Investigator:
- Hsao-Hsun Hsu, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- diagnosed as idiopathic pulmonary artery hypertension and associated family
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: other
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
all cause follow up
Time Frame: eight years
|
all cause follow up
|
eight years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hsao-Hsun Hsu, MD, Department of Surgery, National Taiwan University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
November 1, 2009
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
December 27, 2012
Last Update Submitted That Met QC Criteria
December 26, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9461700712
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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