Hypoxic Pulmonary Vasoconstriction Pilot Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-29

Study Completion Date

2014-01-13

Brief Summary

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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.

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Detailed Description

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Overall goals of this study are to 1) determine the effects on sildenafil on the heterogeneity perfused blood volume in smokers susceptible to emphysema using dual energy CT 2) utilize pulmonary blood volume heterogeneity as an image-based biomarker to differentiate normal and susceptible smokers.

Conditions

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Emphysema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nonsusceptible Smokers (NS)

8 subjects recruited to study non-contrast imaging at TLC and 20%VC and with contrast using DECT to assess perfused blood volume. For the intervention, the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.

Group Type EXPERIMENTAL

Sildenafil study group

Intervention Type DRUG

One dose of 20 mg Sildenafil will be given one hour before CT imaging.

Susceptible Smokers (SS)

11 subjects recruited to study non-contrast imaging at TLC and 20% VC and with contrast using DECT to assess pefused blood volume. For the intervention the subject will be administered 20 mg of Sildenafil and then the same scanning will be repeated one hour after sildenafil administration.

Group Type EXPERIMENTAL

Sildenafil study group

Intervention Type DRUG

One dose of 20 mg Sildenafil will be given one hour before CT imaging.

Interventions

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Sildenafil study group

One dose of 20 mg Sildenafil will be given one hour before CT imaging.

Intervention Type DRUG

Other Intervention Names

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Revatio

Eligibility Criteria

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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).

* Nitroglycerin usage.
* Prior history of hypersensitivity to Sildenafil.

Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes