Hypertension, Pulmonary Clinical Trial
Official title:
Vasodilator Therapy and Exercise Tolerance in IPF Patients
Verified date | September 2017 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis (IPF) patients function better. This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause.
Status | Completed |
Enrollment | 29 |
Est. completion date | June 2009 |
Est. primary completion date | October 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 85 Years |
Eligibility |
Inclusion Criteria: - Clinical diagnosis of IPF - 40-85 years of age - 6-minute walk distance 150-500 m - FVC 40-90% predicted - DLCO 30-90% predicted Exclusion Criteria: - Severe pulmonary hypertension - Severe heart failure - FEV1/FVC < 0.7 |
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Jackson R, Ramos C, Gupta C, Gomez-Marin O. Exercise decreases plasma antioxidant capacity and increases urinary isoprostanes of IPF patients. Respir Med. 2010 Dec;104(12):1919-28. doi: 10.1016/j.rmed.2010.07.021. Epub 2010 Aug 23. — View Citation
Jackson RM, Glassberg MK, Ramos CF, Bejarano PA, Butrous G, Gómez-Marín O. Sildenafil therapy and exercise tolerance in idiopathic pulmonary fibrosis. Lung. 2010 Apr;188(2):115-23. doi: 10.1007/s00408-009-9209-8. Epub 2009 Dec 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in 6-minute Walk Test | Distance in meters -- Distance (meters) walked in 6 minutes | 0 - 6 months | |
Secondary | Dyspnea Score (Borg Scale) | The Dyspnea score or Borg Rating of Perceived Exertion (RPE) Scale score is a subjective rating of perceived exertion. In medicine this is used to document the patient's effort and exertion, breathlessness and fatigue during a physical test. The Dyspnea score ranges from 0 (No breathlessness at all) to 10 (Maximum or extremely strong breathlessness). IN this study the Specific Objective 2 was to assess and compare changes from baseline in pre- and post-exercise dyspnea in the sildenafil and placebo control groups. |
0 - 6 months |
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