Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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19 February 2015 |
Main ID: |
NCT00811486 |
Date of registration:
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18/12/2008 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
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Scientific title:
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Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure |
Date of first enrolment:
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January 2009 |
Target sample size:
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0 |
Recruitment status: |
Withdrawn |
URL:
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http://clinicaltrials.gov/show/NCT00811486 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Shweta Bansal, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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UCHSC |
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Right Heart Failure
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Pulmonary Hypertension
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Intervention(s)
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Drug: Spironolactone and conivaptan
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Primary Outcome(s)
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Cross sectional study
[Time Frame: 18 months]
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Secondary Outcome(s)
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Cross-sectional Study
[Time Frame: 18 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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