View Clinical Trial (Medical Research Study)
Effects of Spironolactone on Collagen Metabolism in Pulmonary Arterial Hypertension
| City: |
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Houston |
| State: |
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Texas |
| Zip Code: |
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77030 |
| Conditions: |
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Pulmonary Hypertension |
| Purpose: |
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The purpose of this study is to determine the effects of spironolactone on collagen
markers in a large number of patients with pulmonary hypertension. In addition, safety and
tolerability of spironolactone, an aldosterone receptor antagonist, in patients with
pulmonary arterial hypertension, will be determined.
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| Study Summary: |
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Pulmonary arterial hypertension (PAH) is an orphan disease characterized by pulmonary artery
hypertrophy, and resulting vascular remodeling of involved vessels, often leading to right
heart failure. Accumulating evidence from vascular biology, animal models, and therapeutic
drug trials suggests significant contributions of the neurohormonal milieu to the disease
process, morbidity, and mortality. The renin-angiotensin-aldosterone system (RAAS) is an
important neurohormonal pathway that induces collagen synthesis in the myocardium and
systemic vasculature. There is paucity of data regarding the contribution of RAAS in the
pathogenesis of PAH and the effects of aldosterone blockade in the amelioration of PAH.
Thus, the overall goal of this proposal is to investigate the contribution of RAAS to the
pathogenesis of PAH, and to explore the effects of an aldosterone blocker, spironolactone,
in PAH.
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| Criteria: |
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Inclusion Criteria:
- Age 18 years or older
- Body weight > 40 kg
- PAH Diagnostic Group I
- Stable subjects with no change in PAH specific therapy within the last 4 weeks
- No change in dose of background therapy (digoxin, diuretic) within the last 2 weeks
excluding anticoagulation
Exclusion Criteria:
- Unable to give informed consent
- Hemodynamically unstable subjects
- Pregnant or breast feeding
- Have significant renal insufficiency (serum creatinine >2.5 mg per deciliter or
required hemodialysis)
- Have significant liver dysfunction (AST or ALT more than three times upper limit of
normal)
- Currently on aldosterone receptor blocker (spironolactone or eplerenone) or ACE
inhibitor
- PH due to left heart disease
- Unable or unwilling to comply with study procedures
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| NCT ID: |
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NCT01468571 |
| Primary Contact: |
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Principal Investigator
Zeenat Safdar, MD
Baylor College of Medicine
Zeenat Safdar, MD
Phone: 713-798-2400
Email: safdar@bcm.edu
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| Backup Contact: |
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Email: gmb@bcm.edu
Gwendolyn Goodloe
Phone: 713-798-2400
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| Location Contact: |
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Houston, Texas 77030
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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