Hypoxic Pulmonary Vasoconstriction Pilot Study

• Status: Completed
• Trial end date: 2014-01-13
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the events leading to smoking-associated centrilobular and paraseptal emphysema are caused by a failure of the lungs' inherent mechanisms to block hypoxic pulmonary vasoconstriction (HPV) in areas of smoking-induced inflammation.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eric A. Hoffman; University of Iowa
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• Must be between the ages of 30 and 60.

• Must be currently smoking at least 1/2 pack/day (confirmed with cotinine level).

• Must have pulmonary function test (PFT) results that meet the following:

• Forced Expiratory Volume at one second (FEV1)/Forced Vital Capacity (FVC) > 70%

• Forced Expiratory Flow at 25-75% (FEF25-75) > 79% of predicted

• FVC greater than 80% of predicted

• Must be able to give informed consent for self.

Exclusion Criteria:

• Pregnant or breastfeeding females.

• Body Mass Index (BMI) greater than 32.

• Weight of greater than 220 pounds (100 kg).

• Allergies to shell fish, seafood, eggs or iodine.

• Heart disease, kidney disease or diabetes.

• Diagnosis of asthma.

• Usage of any medications that are known to affect the heart or lungs (contraceptives, anti-depressants, analgesics EXCEPT aspirin, antihypertensives, and medications for osteoporosis and gastrointestinal diseases will be allowed).

• Any metal in or on the body between the nose and the abdomen.

• Any major organ system disease (by judgment of study medical team).

For the subjects that will receive Sildenafil as part of the study, additional exclusion criteria are as follows:

• Nitroglycerin usage.

• Prior history of hypersensitivity to Sildenafil.