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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: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00811486
Date of registration: 18/12/2008
Prospective Registration: Yes
Primary sponsor: University of Colorado, Denver
Public title: Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
Scientific title: Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure
Date of first enrolment: January 2009
Target sample size: 0
Recruitment status: Withdrawn
URL:  http://clinicaltrials.gov/show/NCT00811486
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Shweta Bansal, MD
Address: 
Telephone:
Email:
Affiliation:  UCHSC
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Right Heart Failure
Pulmonary Hypertension
Intervention(s)
Drug: Spironolactone and conivaptan
Primary Outcome(s)
Cross sectional study [Time Frame: 18 months]
Secondary Outcome(s)
Cross-sectional Study [Time Frame: 18 months]
Secondary ID(s)
07-1022
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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