Targeting the Right Ventricle in Pulmonary Hypertension
|ClinicalTrials.gov Identifier: NCT01839110|
Recruitment Status : Active, not recruiting
First Posted : April 24, 2013
Last Update Posted : June 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Ranolazine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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 normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention.
- Number and percentage of subjects with high risk profile at end of the study [ Time Frame: 6 months ]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 ]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 ]Measure fold changes in glucose and lipid metabolism in subjects with persistent right ventricle dysfunction after treatment with and without ranolazine.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839110
|United States, Maryland|
|University of Maryland|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Missouri|
|Saint Louis, Missouri, United States, 63130|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Yuchi Han, MD||University of Pennsylvania|