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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00240656 |
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Date of registration:
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17/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial Hypertension
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Scientific title:
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Official Title: Spironolactone Combined With Captopril and Carvedilol for the Treatment of Patients With Pulmonary Arterial Hypertension Associated With Congenital Heart Disease—Focus on Pulmonary Artery Remodeling |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00240656 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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China
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Contacts
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Name:
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Kunshen Liu, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hebei Medical University First Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- A mean pulmonary artery pressure higher than 25 mm Hg or, when estimated by
echocardiography, pulmonary artery pressure more than half the systemic artery
pressure
- Congenital systemic-to-pulmonary shunts
Age minimum:
N/A
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension, Pulmonary
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Intervention(s)
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Drug: spironolactone captopril carvedilol
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Primary Outcome(s)
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Blood gas test
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Pulmonary artery pressure (measured by echocardiogram or catheter)
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Change of acropachy
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Dyspnoea score
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NYHA/WHO functional class
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Exercise capacity (six-minute walk)
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Secondary Outcome(s)
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Other echocardiographic changes:
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Pulmonary arterial valve TVI
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Ratio of RV ejection time/RV acceleration time
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Right ventricular (RV) acceleration time (ms)
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Systolic pulmonary arterial pressure
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Change of diameters of both left and right atrium
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Change of right to left shunt expressed by time-velocity integral (TVI) from the defect
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Change of diameters of both left and right ventricles
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Blood gas test
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RV ejection time (ms)
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Change of left to right shunt expressed by TVI from the defect
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Doppler mitral valve (MV) TVI
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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