Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
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ClinicalTrials.gov Identifier: NCT00811486 |
Recruitment Status :
Withdrawn
(Only 1 patient recruited, and he withdrew)
First Posted : December 19, 2008
Last Update Posted : January 28, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Right Heart Failure Pulmonary Hypertension | Drug: Spironolactone and conivaptan | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure |
Study Start Date : | January 2009 |
Actual Primary Completion Date : | July 2010 |
Actual Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
No Intervention: Usual care
Group II
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Experimental: Spironolactone and conivaptan
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 |
- Cross sectional study [ Time Frame: 18 months ]Correlation between severity of pulmonary hypertension and neurohumoral activation, Regional Blood Flow (RBF) & Transcatheter Pulmonary Valve (TPV). Acute study:electrolyte-free water and sodium excretion. Cohort Study: Composite of Cardiac index (CI),brain natriuretic peptide (BNP) and Right Atrial Pressure (RAP)
- Cross-sectional Study [ Time Frame: 18 months ]Correlations between mean pulmonary artery pressure, pulmonary vascular resistance; and neurohumoral activation, glomerular filtration rate (GFR) and Transcatheter Pulmonary Valve (TPV). Acute study:correlation between response to drug and severity of disease.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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 Criteria:
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811486
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, Denver |
ClinicalTrials.gov Identifier: | NCT00811486 |
Other Study ID Numbers: |
07-1022 |
First Posted: | December 19, 2008 Key Record Dates |
Last Update Posted: | January 28, 2013 |
Last Verified: | January 2013 |
Hypertension, Pulmonary Pulmonary Arterial Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Spironolactone Conivaptan |
Mineralocorticoid Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Diuretics, Potassium Sparing Diuretics Natriuretic Agents Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action |