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Sildenafil and Pulmonary Artery Pressure

NCT00145938 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-10-08

No results posted yet for this study

Summary

The purpose of the study is to see if the administration of sildenafil (Viagra) in patients with portopulmonary hypertension could be a safe and effective treatment.

Portopulmonary hypertension (PTPH) is a special type of pulmonary hypertension. Pulmonary hypertension is high blood pressure in the pulmonary arteries that carry unoxygenated blood from the right ventricle of the heart to the lungs. Pulmonary hypertension results from constriction, or tightening, of the blood vessels that supply blood to the lungs. Consequently, it becomes difficult for blood to pass through the lungs, making it harder for the heart to pump blood forward. This stress on the heart leads to enlargement of the heart and eventually fluid can build up in the liver and tissues, such as in the legs. Affected patients can sometimes notice increasing shortness of breath and dizziness.

There is a growing body of evidence suggesting a potential therapeutic role for this sildenafil in patients with primary pulmonary hypertension. Studies are ongoing regarding this area.

Our hypothesis is that chronic oral sildenafil will successfully reduce pulmonary artery pressures by at least 25% (reduction in mean pulmonary artery pressure) and could be an effective treatment for PTPH, especially in candidates for liver transplantation

Primary Hypothesis To measure the effects of a single dose of sildenafil on pulmonary arterial pressure in patients with PTPH

Secondary Hypothesis To measure the effects of chronic (3 month) treatment with sildenafil on pulmonary arterial pressure, safety, and tolerability in patients with PTPH

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

sildenafil

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Allen Anderson, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2006-09-30
Completion
2006-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00145938 on ClinicalTrials.gov