Body Volume Regulation in Pulmonary Arterial Hypertension With Right Ventricular Failure

NCT00811486 | Withdrawn DMC

• 1 other identifier: 07-1022
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Right Heart Failure; Pulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

• Cross sectional study

  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)

  18 months

Secondary Outcomes (1)

• Cross-sectional Study

  18 months

Study Arms (2)

Usual care

NO INTERVENTION

Group II

Spironolactone and conivaptan

EXPERIMENTAL

Group I

Drug: Spironolactone and conivaptan

Interventions

Spironolactone and conivaptan DRUG

Tablet, 50 mg to 200 mg, daily, orally 20 mg intravenously one time over 30 minutes

Spironolactone and conivaptan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• \. 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)

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado at Denver and Health Sciences Center General Clinical Research Center

Denver, Colorado, 80262, United States

Location

MeSH Terms

Conditions

Heart Failure; Hypertension, Pulmonary

Interventions

Spironolactone; conivaptan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Shweta Bansal, MD

  UCHSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2008
• First Posted: December 19, 2008
• Study Start: January 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (1)