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Cystic Fibrosis | Blood Flow and Vascular Function in Cystic Fibrosis

Cystic Fibrosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cystic Fibrosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Acute (1 hour) SildenafilExercise capacity and vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)

Drug:Sub-Chronic (4 weeks) SildenafilExercise capacity and vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks

Drug:PlaceboSugar pill designed to mimic the sildenafil treatment

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

In randomized order, on two separate days, exercise capacity and endothelial function will be determined 1 hour following a single dose of either sildenafil (50 mg) or placebo.

Sub Chronic (4 weeks) SildenafilFollowing the acute study, patients will be instructed to take 20 mg of sildenafil, three times a day, for 4 weeks. Exercise capacity and endothelial function will be determined within 48 hours following the last dose.

Study Status

Active, not recruiting

Start Date: April 2014

Completed Date: December 2018

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Exercise Capacity

Secondary Outcome: Flow-Mediated Dilation (FMD)

Study sponsors, principal investigator, and references

Principal Investigator: Ryan Harris, Ph.D.

Lead Sponsor: Augusta University

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More information:https://clinicaltrials.gov/show/NCT02057458

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