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Sponsored by: |
University of Colorado at Denver and Health Sciences Center |
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Information provided by: | University of Colorado at Denver and Health Sciences Center |
ClinicalTrials.gov Identifier: | NCT00811486 |
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 failure. Natriuretic doses of mineralocorticoid antagonist and aquaretic doses of V2 receptor antagonist will attenuate the sodium and water retention respectively, and be associated with clinical improvement.
Condition | Intervention |
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Right Heart Failure Pulmonary Hypertension |
Drug: Spironolactone and conivaptan Other: usual care |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Efficacy Study |
Official Title: | Body Volume Regulation in Pulmonary Arterial Hypertenison With Right Ventricular Failure |
Estimated Enrollment: | 26 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Usual care
Group II
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Other: usual care
diuretics, PAH specific therapy, O2
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Spironolactone: Experimental
Group I
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Drug: Spironolactone and conivaptan
Tablet, 50 mg to 200 mg, daily, orally 20 mg intravenously one time over 30 minutes
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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 mechanism underlying systemic hypervolemia in patients with isolated right ventricular dysfunction.
Patients with pulmonary arterial hypertension (PAH) represent a model of isolated right ventricular dysfunction in which these mechanisms may be elucidated. Aldosterone has now been shown to have many properties that are likely to be detrimental in congestive heart failure (CHF) and that are not shared by angiotensin II. Aldosterone blockade has been associated with improved mortality in patients with left ventricular failure, already receiving an angiotensin converting enzyme inhibitor. But its role in isolated right ventricular failure has not been elucidated. The plasma arginine vasopressin levels are disproportionately elevated for the degree of serum osmolarity in patients with heart failure and result in water retention and hyponatremia.
Conivaptan, a vasopressin receptor antagonist, appears to reduce body weight and improve signs of left heart failure, though there is no study to evaluate its role in right ventricular failure with edema. This study will examine the role of spironolactone and conivaptan in patients with right ventricular failure and pathophysiology of sodium and water retention in these patients.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
1. Patients with WHO group 1 pulmonary arterial hypertension [51], excluding patients with portal hypertension, meeting the following hemodynamic parameters:
Exclusion Criteria:
1. Group 2-5 pulmonary hypertension as defined by WHO.
Contact: Shweta Bansal, MD | 303-266-9220 | shweta.bansal@uchsc.edu |
Contact: Robert W Schrier, MD | 303-724-4837 | robert.schrier@cudenver.edu |
United States, Colorado | |
University of Colorado at Denver and Health Sciences Center General Clinical Research Center | |
Denver, Colorado, United States, 80262 |
Principal Investigator: | Shweta Bansal, MD | UCHSC |
Responsible Party: | University of Colorado at Denver and Health Sciences Center ( Shweta Bansal ) |
Study ID Numbers: | 07-1022 |
Study First Received: | December 18, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00811486 History of Changes |
Health Authority: | United States: Institutional Review Board |
Heart Failure Heart Diseases Hormone Antagonists Diuretics Vascular Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Cardiovascular Agents |
Hormones Spironolactone Respiratory Tract Diseases Aldosterone Antagonists Hypertension, Pulmonary Lung Diseases Hypertension |
Heart Failure Heart Diseases Hormone Antagonists Diuretics Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Vascular Diseases Cardiovascular Agents Pharmacologic Actions |
Spironolactone Aldosterone Antagonists Respiratory Tract Diseases Hypertension, Pulmonary Natriuretic Agents Therapeutic Uses Lung Diseases Cardiovascular Diseases Hypertension |