Pulmonary Hypertension Clinical Trial
Official title:
Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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