MedTrace Logo

Blood Flow and Vascular Function in Cystic Fibrosis

NCT02057458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2020-04-24

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

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

    collaborator NIH

  • Augusta University

    lead OTHER

Principal Investigators

  • Ryan Harris, Ph.D. · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02057458 on ClinicalTrials.gov