Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

Cystic fibrosis has many health consequences. A reduction in the ability to perform exercise in patients with CF is related to greater death rates, steeper decline in lung function, and more frequent lung infections. However, the physiological mechanisms for this reduced exercise capacity are unknown. The investigators recently published the first evidence of systemic vascular dysfunction in patients with CF. Therefore, it is reasonable to suspect that the blood vessels are involved with exercise intolerance in CF. This study will look at how and if oxidative stress contributes to both artery dysfunction and exercise intolerance in CF.

Key facts

Study ID

NCT02690064

Run by

Augusta University

People needed

13

Starts

2015-04-01

Expected to finish

2027-01-01

Last updated by the study team

2025-01-28

Who can join

Age: 7 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Diagnosis of CF and healthy controls
• Men and women (> 18 yrs. old)
• Boys and girls (7-17 yrs. old)
• FEV1 percent predicted > 30%
• Patients with or without CF related diabetes
• Resting oxygen saturation (room air) >90%
• Traditional CF-treatment medications
• Ability to perform reliable/reproducible PFTs
• Clinically stable for 2 weeks (no exacerbations or need for antibiotic treatment within 2 weeks of testing or major change in medical status)
• Pancreatic sufficient and pancreatic insufficient patients

You may not qualify if…

• Children 6 yrs. old and younger
• FEV1 percent predicted < 30%
• Resting oxygen saturation (room air) < 90%
• Clinical diagnosis of heart disease, PAH
• Febrile illness within two weeks of visit
• Currently smoking, pregnant, or nursing
• Individuals on vaso-active medications (i.e. nitrates, beta blockers, ACE inhibitors, etc.)
• Patients with B. cepacia (only \~3% of our CF center patient population)
• Treatment for pulmonary exacerbation within 4 weeks of a study visit

Where it is running

• Georgia Prevention Institute — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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