Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF (NCT02690064) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF
United States13 participantsStarted 2015-04
Plain-language summary
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.
Who can participate
Age range
7 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acute Change in Flow mediated dilation
Timeframe: Change from baseline (2 hours)
2
Chronic Change in Flow mediated dilation
Timeframe: Baseline, week 4, week 8, and week 12
3
Acute Change in exercise capacity (VO2 peak)
Timeframe: Baseline and 2 hours following acute antioxidant treatment