Status:
COMPLETED
Longitudinal Assessment of Exercise Capacity and Vascular Function in Patients With CF
Lead Sponsor:
Augusta University
Collaborating Sponsors:
Vertex Pharmaceuticals Incorporated
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
7+ years
Brief Summary
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...
Detailed Description
Cystic Fibrosis (CF) is the most common fatal genetic disease in North America. The most disturbing aspect of CF is the associated premature death, most often due to respiratory complications. Clinica...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03338595
Start Date
May 1 2014
End Date
October 1 2020
Last Update
January 19 2021
Active Locations (1)
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1
Georgia Prevention Institute
Augusta, Georgia, United States, 30912