This trial is active, not recruiting.

Condition pulmonary hypertension
Treatments ranolazine, placebo
Sponsor University of Pennsylvania
Collaborator The Cardiovascular Medical Research and Education Fund
Start date July 2013
End date February 2017
Trial size 40 participants
Trial identifier NCT01839110, 817785


This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF <45%) 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day
ranolazine Ranexa
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.
(Placebo Comparator)
Placebo by mouth twice per day
Placebo by mouth twice per day for a total of 26 weeks.
(No Intervention)
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.

Primary Outcomes

Number and percentage of subjects with high risk profile at end of the study
time frame: 6 months

Secondary Outcomes

Glucose and lipid metabolites
time frame: baseline
Changes from baseline in glucose and lipid metabolism
time frame: 6 months

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Symptomatic pulmonary hypertension based on one of the following criteria: Idiopathic pulmonary arterial hypertension, Familial pulmonary arterial hypertension, pulmonary hypertension associated with connective tissue disease, chronic thromboembolic pulmonary hypertension-nonsurgical/distal vessel disease or patients who are reluctant to go to surgery within a 6-month period and are willing to participate, simple congenital such as repaired atrial septal defect or ventricular septal defect or unrepaired small atrial septal defect or ventricular septal defect with persistent and out of proportion pulmonary arterial hypertension, group 3 patients who have a component of pulmonary arterial hypertension, pulmonary arterial hypertension caused by conditions affect the veins and small vessels of the lungs, sickle cell disease, group 5 pulmonary hypertension such as polycythemia vera, essential thrombocythemia, sarcoidosis, or vasculitis, or metabolic disorder. - WHO functional class II, III, or IV - Mean pulmonary artery pressure >25 mmHg at rest - Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg - Baseline 6-minute walk test distance > 50 meters - Stable on baseline existing PH specific therapy for 12 weeks with no dosage change within 28 days prior to screening. Exclusion Criteria: - Previous treatment with or prior sensitivity to ranolazine - Any family history of corrected QT interval prolongation, congenital long QT syndrome, or receiving drugs that prolong the corrected QT interval - Parenchymal lung disease showing total lung capacity < 50% of predicted OR forced expiratory volume at one second/forced vital capacity < 50% - Portal hypertension associated with liver disease - Left sided heart disease including any of the following: moderate or greater aortic or mitral valve disease, Any left ventricle cardiomyopathy, Left ventricular systolic dysfunction defined as an ejection fraction < 50%, Symptomatic coronary artery disease - Uncontrolled hypertension - Uncontrolled diabetes

Additional Information

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
Principal investigator Yuchi Han, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by University of Pennsylvania.