Longitudinal Assessment of Exercise Capacity and Vascular Function in Patients With CF

Completed

Conditions studied: Cystic Fibrosis

In brief

This project is an attempt to understand how Orkambi treatment affects exercise capacity and the function of the arteries in CF patients who are homozygous F508del. Our goal is to perform the exercise and vascular measurements every 3 months after a patient starts taking Orkambi.

Key facts

Study ID

NCT03338595

Run by

Augusta University

People needed

20

Starts

2014-05-01

Expected to finish

2020-10-01

Last updated by the study team

2021-01-19

Who can join

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

You may qualify if…

• Patients diagnosed with Cystic Fibrosis (homozygous deltaF508del)
• Prescribed Orkambi
• Men and women (> 18 yrs. old)
• Boys and girls (7 -17 yrs. old)
• FEV1 percent predicted > 40%
• Resting oxygen saturation (room air) >85%
• Patients with or without CFRD
• Traditional CF-treatment medications
• Clinically stable for past 28 days (no exacerbations or change in medical status)
• Healthy Controls

You may not qualify if…

• Children 6 yrs. old and younger
• FEV1 percent predicted < 40%
• Resting oxygen saturation (room air) < 85%
• Clinical diagnosis of heart disease
• Pulmonary artery hypertension
• Febrile illness within two weeks of visit
• Current smokers
• Currently pregnant or nursing
• Individuals on vaso-active medications (i.e. nitrates, beta blockers, ACE inhibitors, etc.)
• Use of VX-770 within 6 months prior to Visit 1
• History of solid organ transplantation
• Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the patient or the quality of the data.

Where it is running

• Georgia Prevention Institute — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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