Hypoxic Pulmonary Vasoconstriction Pilot Study

Emphysema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733470
• Other study ID #: 201101707
• Secondary ID: 5R01HL112986
• Status: Completed
• Phase: Phase 4
• Start date: June 29, 2011
• Est. completion date: January 13, 2014

Study information

• Verified date: August 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 13, 2014
• Est. primary completion date: January 13, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emphysema
• Pulmonary Emphysema

Intervention

Drug:
• Sildenafil study group
One dose of 20 mg Sildenafil will be given one hour before CT imaging.

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (3)

Lead Sponsor	Collaborator
Eric A. Hoffman	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Alford SK, van Beek EJ, McLennan G, Hoffman EA. Heterogeneity of pulmonary perfusion as a mechanistic image-based phenotype in emphysema susceptible smokers. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7485-90. doi: 10.1073/pnas.0913880107. Epub 2010 Ap — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perfused Blood Volume Assessed for a Change in Lung Inflammation Pre and Post Dose 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.	Change of perfused blood volume from baseline at one hour after sildenafil administration.