Blood Flow and Vascular Function in Cystic Fibrosis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02057458
• Date of registration: 04/02/2014
• Prospective Registration: Yes
• Primary sponsor: Augusta University
• Public title: Blood Flow and Vascular Function in Cystic Fibrosis CF-FLOW
• Scientific title: Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis
• Date of first enrolment: April 2014
• Target sample size: 19
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02057458
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Ryan Harris, Ph.D.
• Affiliation: Augusta University

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Sildenafil (Acute-1 hour)

Drug: Sildenafil (Subchronic-4 weeks)

Drug: Placebo

Primary Outcome(s)

Acute Study: Percentage Flow-Mediated Dilation (FMD) [Time Frame: pre-treatment Baseline and 1 hour post-treatment]

VE Peak [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]

FEV1 (% Predicted) [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]

Baseline Diameter [Time Frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment]

Absolute Change in Diameter [Time Frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment]

Peak Diameter [Time Frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment]

RER Peak [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]

VO2 Peak (Absolute) [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]

VO2 Peak (Percent Predicted) [Time Frame: pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment]

VO2 Peak (Relative) [Time Frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment]

Secondary ID(s)

R21DK100783

DK100783

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

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

Results

• Results available: Yes
• Date Posted: 24/04/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02057458