- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00538044
Simvatstatin Used to Treat Pulmonary Hypertension
October 1, 2007 updated by: Capital Medical University
the Clinical Research Using Simvastatin as a Medication to Treat Advanced Secondary Pulmonary Hypertension
we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.
Study Overview
Detailed Description
advanced pulmonary hypertension is refractory to the medication in use nowaday, especially pulmonary hypertension secondary to congenital heart disease or chronic pulmonary embolism.It is revealed that statins may intefere the pathogenisis of the pulmonary hypertension in many key poing, such as improving apotosis or inhiting the proliferation of pulmonary vascular smooth muscle cell.
so we try to use simvastatin in the treatment of advanced pulmoary hypertension secondary to congenital heart disease or chronic pulmonary embolism before and after the operation.
Study Type
Interventional
Phase
- Phase 1
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
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Beijing, China, 100029
- Beijing Anzhen Hospital
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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
12 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pasp>50mmHg
Exclusion Criteria:
- pasp<50mmhg
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1simvastatin group
before the operation, the patient start the simvastatin medication on the dosage of 40mg per day
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medication with simvastation on the dosage of 40mg per day before the operation and all the time after the operation
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No Intervention: 2contral group
just do routin operation with no use of simvastatin, other medication is exact the same as the simvastatin group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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the simvastatin can alleviate pulmonary hypertension
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pulmonary pressure
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Secondary Outcome Measures
Outcome Measure |
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simvastatin can highten the perioperative and long term survaval rate and the living quality
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Huili Gan, MD,Ph.D., Beijing Anzehn hospital
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
January 1, 2009
Study Completion (Anticipated)
January 1, 2012
Study Registration Dates
First Submitted
October 1, 2007
First Submitted That Met QC Criteria
October 1, 2007
First Posted (Estimate)
October 2, 2007
Study Record Updates
Last Update Posted (Estimate)
October 2, 2007
Last Update Submitted That Met QC Criteria
October 1, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Hypertension
- Hypertension, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Simvastatin
Other Study ID Numbers
- Gan1
- Anzhen1
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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