NCT02690064Active, not recruiting
Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF
Source: ClinicalTrials.gov · Last updated 28 Jan 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 13 (actual)
- First submitted
- 19 Feb 2016
- Start date
- 1 Apr 2015
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Augusta University
- Diseases
- Cystic fibrosis
- NCT number
- NCT02690064
What you commit to
- Study type: Interventional
- Participants enrolled: 13
- From 1 Apr 2015 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals on vaso-active medications (i.e. nitrates, beta blockers, ACE inhibitors, etc.)
Other illness
- Clinical diagnosis of heart disease, PAH
- Febrile illness within two weeks of visit
Other
- Children 6 yrs. old and younger
- FEV1 percent predicted \< 30%
- Resting oxygen saturation (room air) \< 90%
- Currently smoking, pregnant, or nursing
- Patients with B. cepacia (only \~3% of our CF center patient population)
- Treatment for pulmonary exacerbation within 4 weeks of a study visit
Who the study is looking for
- 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
Age in the registry: 7 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Georgia prevention institute Coordinator of this site? Confirm its status | Augusta | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.