Targeting the Right Ventricle in Pulmonary Hypertension
This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF <=40%) would improve their outcome. This study is accompanied by a baseline comparison of the metabolic profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine on Outcomes in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Accompanied by a Comparative Study of Cellular Metabolism in Subjects With Pulmonary Hypertension With and Without Right Ventricular Dysfunction|
- Number and percentage of subjects with high risk profile at end of the study [ Time Frame: 6 months ] [ Designated as safety issue: No ]Number and percentage of subjects with high risk profile at Week 26. Patients with high risk profile are defined as patients with clinical worsening events or lack of clinical improvement at the end of the study.
- Glucose and lipid metabolites [ Time Frame: baseline ] [ Designated as safety issue: No ]Measure differences in glucose and lipid metabolism in subjects with and without RV dysfunction at baseline.
- Changes from baseline in glucose and lipid metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]Measure fold changes in glucose and lipid metabolism in subjects with persistent right ventricle dysfunction after treatment with and without ranolazine.
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||September 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Ranolazine
Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day
Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.
Other Name: Ranexa
Placebo Comparator: Placebo
Placebo by mouth twice per day
Placebo by mouth twice per day for a total of 26 weeks.
No Intervention: Observational
Patients with pulmonary hypertension who have near normal RV function (RVEF >40%) will undergo same procedures in the observational arm but will not receive an intervention.
|Contact: Yuchi Han, MDemail@example.com|
|Contact: Amanda Baer, MB, MBAfirstname.lastname@example.org|
|United States, Maryland|
|University of Maryland||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Myung Park, MD email@example.com|
|Contact: Lioubov Poliakova firstname.lastname@example.org|
|Principal Investigator: Myung Park, MD|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Aaron Waxman, MD, PhD email@example.com|
|Contact: Laurie Lawler, RN firstname.lastname@example.org|
|Principal Investigator: Aaron Waxman, MD, PhD|
|United States, Pennsylvania|
|University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Yuchi Han, MD email@example.com|
|Contact: Amanda Baer, MB, MBA firstname.lastname@example.org|
|Principal Investigator: Yuchi Han, MD|
|Principal Investigator:||Yuchi Han, MD||University of Pennsylvania|