Blood Flow and Vascular Function in Cystic Fibrosis (CF-FLOW)
|ClinicalTrials.gov Identifier: NCT02057458|
Recruitment Status : Active, not recruiting
First Posted : February 7, 2014
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Drug: Acute (1 hour) Sildenafil Drug: Sub-Chronic (4 weeks) Sildenafil Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis|
|Actual Study Start Date :||April 2014|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||December 2018|
U.S. FDA Resources
Experimental: Acute (1 hour) Sildenafil & Placebo
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.
Drug: Acute (1 hour) Sildenafil
Exercise capacity and vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)
Other Names:Drug: Placebo
Sugar pill designed to mimic the sildenafil treatment
Experimental: Sub Chronic (4 weeks) Sildenafil
Following 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.
Drug: Sub-Chronic (4 weeks) Sildenafil
Exercise capacity and vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks
- Exercise Capacity [ Time Frame: 1 hour ]Exercise Capacity will be determined one hour after ingestion of 50 mg Sildenafil
- Exercise Capacity [ Time Frame: 4 weeks ]Exercise capacity will be determined after taking 20 mg of Sildenafil thrice daily for four weeks.
- Flow-Mediated Dilation (FMD) [ Time Frame: 1 hour and 4 weeks ]Brachial artery FMD induced by reactive hyperemia will be used to assess vascular endothelial function.
- Arterial Stiffness Evaluation (PWV) [ Time Frame: 1 hour and 4 weeks ]A tonometer will be gently applied on the carotid artery and then the femoral artery and the radial artery to record how fast blood flows between each of the points.
- Physio Flow [ Time Frame: 1 hour and 4 weeks ]Six surface electrodes will be placed on the body. 2 on the neck, 2 on the chest, and 2 on the back in order to measure parameters of the heart during exercise.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057458
|United States, Georgia|
|Georgia Regents University|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Ryan Harris, Ph.D.||Augusta University|