NCT00538044

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2009

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

October 2, 2007

Status Verified

September 1, 2007

First QC Date

October 1, 2007

Last Update Submit

October 1, 2007

Conditions

Hypertension, Pulmonary

Keywords

pulmonary hypertensionsimvastatinadvanced pulmonary hypertension secondary to congenital heart diseaseadvanced pulmonary hypertension secondary to chronic pulmonary embolism

Outcome Measures

Primary Outcomes (2)

  • the simvastatin can alleviate pulmonary hypertension

  • pulmonary pressure

Secondary Outcomes (1)

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

Study Arms (2)

1simvastatin group

EXPERIMENTAL

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

Drug: simvastatin

2contral group

NO INTERVENTION

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

Interventions

simvastatinDRUG

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

1simvastatin group

Eligibility Criteria

Age12 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • pasp\>50mmHg

You may not qualify if:

  • pasp\<50mmhg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Anzhen Hospital

Beijing, 100029, China

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Huili Gan, MD,Ph.D.

    Beijing Anzehn Hospital

    STUDY CHAIR

Central Study Contacts

Huili Gan, MD,Ph.D.

CONTACT

13001277863ganhuili@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

January 1, 2009

Study Completion

January 1, 2012

Last Updated

October 2, 2007

Record last verified: 2007-09

Locations

CN(1)