Back to results

Simvatstatin Used to Treat Pulmonary Hypertension

Primary Purpose

Hypertension, Pulmonary

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

simvastatin

About this trial

This is an interventional treatment trial for Hypertension, Pulmonary focused on measuring pulmonary hypertension, simvastatin, advanced pulmonary hypertension secondary to congenital heart disease, advanced pulmonary hypertension secondary to chronic pulmonary embolism

Eligibility Criteria

12 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

pasp>50mmHg

Exclusion Criteria:

pasp<50mmhg

Sites / Locations

Beijing Anzhen Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

1simvastatin group

2contral group

Arm Description

before the operation, the patient start the simvastatin medication on the dosage of 40mg per day

just do routin operation with no use of simvastatin, other medication is exact the same as the simvastatin group

Outcomes

Primary Outcome Measures

the simvastatin can alleviate pulmonary hypertension

pulmonary pressure

Secondary Outcome Measures

simvastatin can highten the perioperative and long term survaval rate and the living quality

Full Information

NCT ID

NCT00538044

First Posted

October 1, 2007

Last Updated

October 1, 2007

Sponsor

Capital Medical University

1. Study Identification

Unique Protocol Identification Number

NCT00538044

Brief Title

Simvatstatin Used to Treat Pulmonary Hypertension

Official Title

the Clinical Research Using Simvastatin as a Medication to Treat Advanced Secondary Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Unknown status

Study Start Date

January 2009 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Capital Medical University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Pulmonary

Keywords

pulmonary hypertension, simvastatin, advanced pulmonary hypertension secondary to congenital heart disease, advanced pulmonary hypertension secondary to chronic pulmonary embolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

8. Arms, Groups, and Interventions

Arm Title

1simvastatin group

Arm Type

Experimental

Arm Description

before the operation, the patient start the simvastatin medication on the dosage of 40mg per day

Arm Title

2contral group

Arm Type

No Intervention

Arm Description

just do routin operation with no use of simvastatin, other medication is exact the same as the simvastatin group

Intervention Type

Drug

Intervention Name(s)

simvastatin

Intervention Description

medication with simvastation on the dosage of 40mg per day before the operation and all the time after the operation

Primary Outcome Measure Information:

Title

the simvastatin can alleviate pulmonary hypertension

Title

pulmonary pressure

Secondary Outcome Measure Information:

Title

simvastatin can highten the perioperative and long term survaval rate and the living quality

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: pasp>50mmHg Exclusion Criteria: pasp<50mmhg

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huili Gan, MD,Ph.D.

Phone

13001277863

ganhuili@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huili Gan, MD,Ph.D.

Organizational Affiliation

Beijing Anzehn Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Beijing Anzhen Hospital

City

Beijing

ZIP/Postal Code

100029

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Huili Gan, MD, Ph.D.

Phone

861013001277863

ganhuili@hotamail.com

12. IPD Sharing Statement

Learn more about this trial

Simvatstatin Used to Treat Pulmonary Hypertension

We'll reach out to this number within 24 hrs