Blood Flow and Vascular Function in Cystic Fibrosis (CF-FLOW)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|