A Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension
|ClinicalTrials.gov Identifier: NCT01757808|
Recruitment Status : Completed
First Posted : December 31, 2012
Last Update Posted : March 3, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension||Drug: Ranolazine Drug: Placebo||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase I Study of Ranolazine Acute Administration and Short Term Administration in Pulmonary Arterial Hypertension|
|Study Start Date :||August 2011|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
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
- Change in pulmonary vascular resistance (PVR) [ Time Frame: 12 weeks ]
- 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 ]
- Change in RV echo parameters: 2D, 3D [ Time Frame: 12 weeks ]
- Change in 6MWD [ Time Frame: 12 weeks ]
- Safety/SAE [ Time Frame: 12 weeks ]AE and SAE on study drug and acutely changes in blood pressure and PAP
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757808
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Mardi Gomberg-Maitland, MD||University of Chicago|