NCT02057458

Blood Flow and Vascular Function in Cystic Fibrosis

Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The most disturbing aspect of Cystic Fibrosis (CF) is the associated premature death. Low exercise capacity predicts death in patients with CF and is also associated with a steeper decline in lung function and more lung infections. A critical barrier to improving exercise tolerance in patients with CF is the investigators lack of knowledge regarding the different physiological mechanisms which contribute to their lower exercise capacity. We have compelling data to indicate that the blood vessels may contribute to the low exercise capacity in CF. The impact of this proof of concept investigation will test Phosphodiesterase Type 5 inhibitors (PDE5) inhibitors as a potential therapy in CF and will explore blood flow and endothelial function as potential mechanisms which contribute to exercise intolerance in CF. Improvements in exercise capacity will not only contribute to a better quality of live for patients with CF, it will also increase longevity in these patients.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	Sildenafil (Acute-1 hour)	Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)
DRUG	Sildenafil (Subchronic-4 weeks)	Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks
DRUG	Placebo	Sugar pill designed to mimic the sildenafil treatment

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2014-02-07
• Last updated: 2020-04-24
• Results posted: 2020-04-24

Locations

1 site across 1 country: United States