Body Volume Regulation in Pulmonary Arterial Hypertension With Right

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00811486
Study type	Interventional
Source	University of Colorado, Denver
Contact
Status	Withdrawn
Phase	N/A
Start date	January 2009
Completion date	December 2010

View Details

See also
Status	Clinical Trial	Phase
Withdrawn	`NCT01950585` - Hydroxyurea in Pulmonary Arterial Hypertension	Early Phase 1
Completed	`NCT00527163` - Role of Nitric Oxide in Malaria
Completed	`NCT03649932` - Enteral L Citrulline Supplementation in Preterm Infants - Safety, Efficacy and Dosing	Phase 1
Recruiting	`NCT04554160` - Arrhythmias in Pulmonary Hypertension Assessed by Continuous Long-term Cardiac Monitoring
Enrolling by invitation	`NCT03683186` - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension	Phase 3
Completed	`NCT01894035` - Non-interventional Multi-center Study on Patients Under Routine Treatment of Pulmonary Arterial Hypertension (PAH) With Inhaled Iloprost Using I-Neb as a Device for Inhalation
Not yet recruiting	`NCT04083729` - Persistent Pulmonary Hypertension After Percutaneous Mitral Commissurotomy	N/A
Completed	`NCT02821156` - Study on the Use of Inhaled NO (iNO)	N/A
Terminated	`NCT02243111` - Detecting Pulmonary Arterial Hypertension (PAH) in Patients With Systemic Sclerosis (SSc) by Ultrasound	N/A
Terminated	`NCT02246348` - Evaluating Lung Doppler Signals in Patients With Systemic Sclerosis (SSc)	N/A
Completed	`NCT02216279` - Phase-II Study of the Use of PulmoBind for Molecular Imaging of Pulmonary Hypertension	Phase 2
Recruiting	`NCT01913847` - Safety and Efficacy Study of HGP1207 in Patients With Pulmonary Hypertension	Phase 3
Completed	`NCT01615484` - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability	N/A
Completed	`NCT06240871` - Contrast Enhanced PA Pressure Measurements
Completed	`NCT02377934` - Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Recruiting	`NCT01091012` - Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension	Phase 3
Completed	`NCT01484899` - Smoking: a Risk Factor for Pulmonary Arterial Hypertension?	N/A
Completed	`NCT02275793` - The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Completed	`NCT01463514` - Noninvasive Determination of Cerebral Tissue Oxygenation in Pulmonary Hypertension	N/A
Completed	`NCT00739375` - The Effect of Blood Flow in the Maturing Arteriovenous Access for Hemodialysis on the Development of Pulmonary Hypertension.	Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms