Targeting the Right Ventricle in Pulmonary Hypertension
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|ClinicalTrials.gov Identifier: NCT01839110|
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : December 19, 2018
Last Update Posted : December 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Hypertension||Drug: Ranolazine Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 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|
|Actual Study Start Date :||July 2013|
|Actual Primary Completion Date :||January 2018|
|Actual Study Completion Date :||January 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.
- Changes in Right Ventricular Ejection Fraction [ Time Frame: 6 months ]right ventricular ejection fraction by cardiac MRI Patients with high risk profile are defined as patients with clinical worsening events or lack of clinical improvement at the end of the study.
- 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.
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): 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, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Yuchi Han, MD||University of Pennsylvania|