Targeting the Right Ventricle in Pulmonary Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Ranolazine; Placebo
Intervention description: 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 by mouth twice per day for a total of 26 weeks.
Intervention MeSH terms: Ranolazine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: pulmonary hypertension; right ventricular function; ranolazine

Summary:

      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.
    

Eligibility criteria:

        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