Cystic Fibrosis and Endothelial Function: At Rest and During Exercise
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 7 - Any |
| Updated: | 1/12/2018 |
| Start Date: | August 2011 |
| End Date: | June 21, 2016 |
Influence of Cystic Fibrosis on Vascular Endothelial Function at Rest and During Exercise
Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated
premature death. Oxidative stress has been observed in patients with CF and exercise
intolerance has been shown to predict mortality in patients with CF, regardless of how
healthy their lungs are. A critical barrier to improving the quality of life and longevity in
patients with CF is our lack of knowledge regarding the different reasons why patients with
CF cannot exercise to the level of their peers. We have collected preliminary data to support
our central hypothesis that oxidative stress contributes to the impairment in blood vessel
function at rest and during exercise which ultimately oxygen transport and delivery resulting
in exercise intolerance. Exercise is therapeutic medicine for patients with CF and this
investigation represents a major breakthrough in the approach to begin understanding the
physiological mechanisms which contribute to exercise intolerance in these patients.
premature death. Oxidative stress has been observed in patients with CF and exercise
intolerance has been shown to predict mortality in patients with CF, regardless of how
healthy their lungs are. A critical barrier to improving the quality of life and longevity in
patients with CF is our lack of knowledge regarding the different reasons why patients with
CF cannot exercise to the level of their peers. We have collected preliminary data to support
our central hypothesis that oxidative stress contributes to the impairment in blood vessel
function at rest and during exercise which ultimately oxygen transport and delivery resulting
in exercise intolerance. Exercise is therapeutic medicine for patients with CF and this
investigation represents a major breakthrough in the approach to begin understanding the
physiological mechanisms which contribute to exercise intolerance in these patients.
The overall goals of this proposal are to provide mechanistic evidence that oxidative stress
contributes to 1) endothelial dysfunction and 2) exercise intolerance in patients with CF.
This study consists of two separate sub-studies, or protocols. Protocol 1: AOC tested the
effect of an antioxidant cocktail (AOC) on endothelial function at rest and during exercise
in CF patients. Protocol 2: BH4 tested the effect of tetrahydrobiopterin (BH4) on endothelial
function at rest and during exercise in CF patients.
contributes to 1) endothelial dysfunction and 2) exercise intolerance in patients with CF.
This study consists of two separate sub-studies, or protocols. Protocol 1: AOC tested the
effect of an antioxidant cocktail (AOC) on endothelial function at rest and during exercise
in CF patients. Protocol 2: BH4 tested the effect of tetrahydrobiopterin (BH4) on endothelial
function at rest and during exercise in CF patients.
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%
- Resting oxygen saturation (room air) >90%
- Patients with or without CFRD
- 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)
Exclusion Criteria:
- Children 6 yrs. old and younger
- FEV1 percent predicted < 30%
- Resting oxygen saturation (room air) < 90%
- 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.)
- Inability to swallow pills
- Patients with B. Cepacia (only ~3% of our CF center patient population)
We found this trial at
1
site
1441-1447 Walton Way
Augusta, Georgia 30912
Augusta, Georgia 30912
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