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Completed

NCT Number: NCT03733470

Hypoxic Pulmonary Vasoconstriction Pilot Study

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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Key information

Conditions

Emphysema Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sildenafil study group

Drug

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

Other names: Revatio

Primary outcomes

  1. Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose Sildenafil Administration

    Time frame: Change of perfused blood volume from baseline at one hour after sildenafil administration.

    Perfused blood volume will be measured by CT scan at two time points and compared at two points, pre and post the administration of sildenafil.

Sponsors and collaborators

Lead sponsor

Eric A. Hoffman

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Pilot Study for Perfusion Heterogeneity: a Mechanistic Image-Based Emphysema Phenotype

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2018
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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