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Effects of Spironolactone on Collagen Metabolism in Patients With Pulmonary Arterial Hypertension

Information source: Baylor College of Medicine
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Hypertension

Intervention: Spironolactone (Drug); Placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Baylor College of Medicine

Official(s) and/or principal investigator(s):
Zeenat Safdar, MD, Principal Investigator, Affiliation: Baylor College of Medicine

Overall contact:
Zeenat Safdar, MD, Phone: 713-798-2400, Email: safdar@bcm.edu

Summary

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.

Clinical Details

Official title: Effects of Spironolactone on Collagen Metabolism in Pulmonary Arterial Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: Change in biomarker levels in the spironolactone treated as compared to placebo treated group.

Secondary outcome:

Number of adverse events in patients treated with spironolactone as compared to placebo.

Change in six-minute walk distance from baseline to week 8 and week 16.

Composite end-point

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Zeenat Safdar, MD, Phone: 713-798-2400, Email: safdar@bcm.edu

Baylor College of Medicine, Houston, Texas 77030, United States; Recruiting
Additional Information

Starting date: July 2011
Last updated: February 4, 2013

Page last updated: February 07, 2013

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