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Simvatstatin Used to Treat Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT00538044
Recruitment Status : Unknown
Verified September 2007 by Capital Medical University.
Recruitment status was:  Not yet recruiting
First Posted : October 2, 2007
Last Update Posted : October 2, 2007
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hypertension, Pulmonary Drug: simvastatin Phase 1

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 Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: the Clinical Research Using Simvastatin as a Medication to Treat Advanced Secondary Pulmonary Hypertension
Study Start Date : January 2009
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1simvastatin group
before the operation, the patient start the simvastatin medication on the dosage of 40mg per day
Drug: simvastatin
medication with simvastation on the dosage of 40mg per day before the operation and all the time after the operation
No Intervention: 2contral group
just do routin operation with no use of simvastatin, other medication is exact the same as the simvastatin group


Outcome Measures

Primary Outcome Measures :
  1. the simvastatin can alleviate pulmonary hypertension
  2. pulmonary pressure

Secondary Outcome Measures :
  1. simvastatin can highten the perioperative and long term survaval rate and the living quality

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pasp>50mmHg

Exclusion Criteria:

  • pasp<50mmhg
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538044


Contacts
Contact: Huili Gan, MD,Ph.D. 13001277863 ganhuili@hotmail.com

Locations
China
Beijing Anzhen Hospital Not yet recruiting
Beijing, China, 100029
Contact: Huili Gan, MD, Ph.D.    861013001277863    ganhuili@hotamail.com   
Sponsors and Collaborators
Capital Medical University
Investigators
Study Chair: Huili Gan, MD,Ph.D. Beijing Anzehn Hospital
More Information

ClinicalTrials.gov Identifier: NCT00538044     History of Changes
Other Study ID Numbers: Gan1
Anzhen1
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: October 2, 2007
Last Verified: September 2007

Keywords provided by Capital Medical University:
pulmonary hypertension
simvastatin
advanced pulmonary hypertension secondary to congenital heart disease
advanced pulmonary hypertension secondary to chronic pulmonary embolism

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors