A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
The purpose of this study is to assess the safety of ranolazine in people with pulmonary arterial hypertension (PAH) and who are receiving 1 or more background PAH therapies: ambrisentan, sildenafil,tadalafil, epoprostenol, treprostinil (IV, SC, inhaled), or iloprost. The primary objective is:
- To estimate the effect of ranolazine administration on acute hemodynamics.
- To assess safety of ranolazine acutely over 6 hrs in the catheterization lab and after 12 weeks of therapy
- To assess changes in right ventricular function after 12 weeks of therapy.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension|
- Change in pulmonary vascular resistance (PVR) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Change in CPET (VE/VCO2, PETCO2, peak VO2, peak HR, peak RER, work max (MET or Watt), sub maximum exercise time [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Change in RV echo parameters: 2D, 3D [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Change in 6MWD [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Safety/SAE [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]AE and SAE on study drug and acutely changes in blood pressure and PAP
|Study Start Date:||August 2011|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
ranolazine sustained release at a dose of 500mg for one month followed by a dose of 1000mg.
Other Name: GS-9668
|Placebo Comparator: Placebo||
placebo at a dose of 500mg for one month followed by a dose of 1000mg.
Other Name: sugar pill
Pulmonary arterial hypertension is a medical disorder in which pressure in the blood vessels going from the right side of the heart to the lungs is higher than normal. The increased blood pressure in the lungs places a strain on the heart. This strain causes the heart to pump less blood into the lungs, causing physical symptoms of shortness of breath and tiredness. The added strain to the heart can cause physical symptoms of swelling in the feet and abdomen. These symptoms can get worse over time due to the decreased pumping ability of the heart.
This study will use a drug called ranolazine. This drug has been approved by the Food and Drug Administration (FDA) to treat chronic angina (chest pain). However, since it has not been approved for use in PAH its use in this study is considered experimental.
|Contact: Mardi Gomberg-Maitland, MDfirstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Principal Investigator: Mardi Gomberg-Maitland, MD|
|Principal Investigator:||Mardi Gomberg-Maitland, MD||University of Chicago|