Ignite Creation Date:
2024-05-05 @ 9:05 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00811486
Status:
WITHDRAWN
Last Update Posted:
2013-01-28
First Post:
2008-12-18
Brief Title:
Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
Status:
WITHDRAWN
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Only 1 patient recruited and he withdrew
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None