Phase 2
N=19
Blood Flow and Vascular Function in Cystic Fibrosis
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT02057458 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcome: Primary: Acute Study: Percentage Flow-Mediated Dilation (FMD) — 7.8; 7.7; 7.3; 6.6 percent flow mediated dilation
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sildenafil (Acute-1 hour) (Drug); Sildenafil (Subchronic-4 weeks) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Augusta University
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acute Study: Percentage Flow-Mediated Dilation (FMD) |
7.8; 7.7; 7.3; 6.6 | — |
| PRIMARY Baseline Diameter |
3.00; 3.06 | — |
| PRIMARY Peak Diameter |
3.22; 3.30 | — |
| PRIMARY Absolute Change in Diameter |
0.21; 0.27 | — |
| PRIMARY FEV1 (% Predicted) |
81; 75; 75; 82 | — |
| PRIMARY VO2 Peak (Absolute) |
1.5; 1.7; 1.6; 1.6 | — |
| PRIMARY VO2 Peak (Relative) |
28.5; 29.3; 26.8; 29.5 | — |
| PRIMARY VO2 Peak (Percent Predicted) |
72; 77; 72; 75 | — |
| PRIMARY VE Peak |
65; 81; 77; 72 | — |
| PRIMARY RER Peak |
1.31; 1.17; 1.22; 1.18 | — |
Summary
Cystic fibrosis (CF) 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 laboratory 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 1) blood flow and 2) artery function contribute to exercise capacity in CF.
Eligibility Criteria
Inclusion Criteria.
- Diagnosis of CF and healthy controls
- Men and women (greater than 18 yrs. old)
- Resting oxygen saturation (room air) greater than 90%
- Forced expiratory volume (FEV1) percent predicted greater than 30%
- Patients with or without CF related diabetes
- Traditional CF-treatment medications
- Ability to perform reliable/reproducible pulmonary function tests (PFT)
- 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 less than 17 years old
- Body mass less than 20 kg
- A diagnosis of pulmonary arterial hypertension (PAH)
- FEV1 less than 30% of predicted
- Resting oxygen saturation (SpO2) less than 90%
- Self-reported to be a smoker
- Current use of any vaso-active medications
- History of migraine headaches
- Pregnant or nursing at the time of the investigation
- A clinical diagnosis of cardiovascular disease, hypertension, or CF related diabetes
Data sourced from ClinicalTrials.gov (NCT02057458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.