Spironolactone Combined With Captopril and Carvedilol for the Treatment of Pulmonary Arterial Hypertension
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00240656 |
Recruitment Status :
Completed
First Posted : October 18, 2005
Last Update Posted : June 30, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertension, Pulmonary | Drug: spironolactone captopril carvedilol | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | October 2005 |
Study Completion Date : | May 2006 |

- Dyspnoea score
- Exercise capacity (six-minute walk)
- NYHA/WHO functional class
- Change of acropachy
- Blood gas test
- Pulmonary artery pressure (measured by echocardiogram or catheter)
- Other echocardiographic changes:
- Systolic pulmonary arterial pressure
- Change of right to left shunt expressed by time-velocity integral (TVI) from the defect
- Change of left to right shunt expressed by TVI from the defect
- Right ventricular (RV) acceleration time (ms)
- RV ejection time (ms)
- Ratio of RV ejection time/RV acceleration time
- Pulmonary arterial valve TVI
- Change of diameters of both left and right ventricles
- Change of diameters of both left and right atrium
- Doppler mitral valve (MV) TVI
- Blood gas test

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Ages Eligible for Study: | up to 80 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT00240656
China, Hebei | |
The First Hospital of Hebei Medical University | |
Shijiazhuang, Hebei, China, 050031 |
Study Chair: | Kunshen Liu, M.D. | The First Hospital of Hebei Medical University |
ClinicalTrials.gov Identifier: | NCT00240656 |
Other Study ID Numbers: |
0510-A |
First Posted: | October 18, 2005 Key Record Dates |
Last Update Posted: | June 30, 2008 |
Last Verified: | October 2005 |
aldosterone antagonists, spironolactone, captopril carvedilol |
Hypertension, Pulmonary Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Carvedilol Captopril Spironolactone Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics |
Natriuretic Agents Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Antioxidants Protective Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |