Status:
WITHDRAWN
Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
Lead Sponsor:
University of Colorado, Denver
Conditions:
Right Heart Failure
Pulmonary Hypertension
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Secondary hyperaldosteronism and the non-osmotic release of arginine vasopressin (AVP) are the major factors in sodium and water retention in pulmonary arterial hypertension with right ventricular fai...
Detailed Description
Much has been learned about the pathophysiological state that underlies the development of increased total body volume and edema in left ventricular failure. Very little, however, is known about the m...
Eligibility Criteria
Inclusion
- 1\. Patients with World Health Organization (WHO) group 1 pulmonary arterial hypertension \[51\], excluding patients with portal hypertension, meeting the following hemodynamic parameters:
- Mean pulmonary artery pressure (mPAP) \>35 mmHg at rest, and
- Pulmonary capillary wedge pressure (PCWP) \<15 mmHg, and
- Pulmonary vascular resistance (PVR) \>1.5 wood units, and 2. Age 18 to 75 years 3. Right ventricular failure defined by right atrial pressure \>7 mmHg along with either dilated right ventricle, or absence of inferior vena cava collapse or BNP \>100 pg/ml 4. Patients of childbearing age must be practicing effective birth control. 5. Normal left ventricular function as assessed by echocardiogram, multiple gated acquisition (MUGA) cardiac scan, or invasive left ventriculography.
Exclusion
- 1\. Group 2-5 pulmonary hypertension as defined by WHO.
- Pulmonary hypertension with left heart failure (as assessed by echocardiogram, multiple gated acquisition (MUGA) cardiac scan, or invasive left ventriculography).
- Pulmonary hypertension associated with lung disease and/or hypoxemia (e.g. chronic obstructive pulmonary disease, interstitial lung disease, sleep disordered breathing, chronic exposure to high altitude, alveolar hypoventilation syndrome.
- Pulmonary hypertension due to chronic thrombotic and/or embolic diseases
- Miscellaneous such as sarcoidosis, compression of pulmonary vessels by adenopathy, tumor 2. Systemic hypertension, defined as a systolic pressure \>140 mmHg or a diastolic blood pressure \>90 mmHg 3. Patients taking angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blockers (ARBs) 4. Pregnancy 5. Chronic kidney disease (serum creatinine \> 2.5mg/dl, proteinuria \>500 mg/day, hematuria) 6. Cirrhosis or portal hypertension 7. Inability to provide informed consent. 8. Allergy to conivaptan or spironolactone. 9. Active malignancy 10. Patients receiving spironolactone 11. Enrollment in other interventional studies. 12. Patients on Highly Active Antiretroviral Therapy (HAART)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00811486
Start Date
January 1 2009
End Date
December 1 2010
Last Update
January 28 2013
Active Locations (1)
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1
University of Colorado at Denver and Health Sciences Center General Clinical Research Center
Denver, Colorado, United States, 80262