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NCT Number: NCT02057458

Blood Flow and Vascular Function in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Inflammation Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Augusta University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil (Acute-1 hour)

Drug

Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)

Other names: Viagra, Revatio

Sildenafil (Subchronic-4 weeks)

Drug

Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks

Other names: Viagra, Revatio

Placebo

Drug

Sugar pill designed to mimic the sildenafil treatment

Primary outcomes

  1. Acute Study: Percentage Flow-Mediated Dilation (FMD)

    Time frame: pre-treatment Baseline and 1 hour post-treatment

    FMD determined one hour after ingestion of 50 mg Sildenafil or placebo

  2. Baseline Diameter

    Time frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment

    Brachial Artery Diameter during FMD (pre-occlusion or "baseline")

  3. Peak Diameter

    Time frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment

    Peak Brachial Artery Diameter during FMD (post-occlusion)

  4. Absolute Change in Diameter

    Time frame: pre-treatment Baseline and following 4 weeks sub-chronic treatment

    Absolute change in brachial artery diameter taken from the FMD assessment

  5. FEV1 (% Predicted)

    Time frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment

    Forced Expiratory Volume in the first second expressed as a percent predicted.

  6. VO2 Peak (Absolute)

    Time frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment

    absolute (L/min) peak oxygen consumption during maximal exercise test

  7. VO2 Peak (Relative)

    Time frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment

    relative (mL/kg/min) peak oxygen consumption during maximal exercise test

  8. VO2 Peak (Percent Predicted)

    Time frame: pre-treatment Baseline and 1 hour post-treatment, and 4 weeks sub-chronic treatment

    Maximal Oxygen consumption expressed as percent predicted taken from maximal exercise test.

  9. VE Peak

    Time frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment

    peak ventilation (L/min) during maximal exercise test

  10. RER Peak

    Time frame: pre-treatment Baseline, 1 hour post-treatment, and following 4 weeks sub-chronic treatment

    peak respiratory exchange ratio during maximal exercise test

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

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

Registry information

Official study title

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

Acronym: CF-FLOW

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2014
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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