Targeting Right Ventricle in Pulmonary Hypertension Gilead
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Hypertension
Intervention: Ranolazine; Placebo
Intervention description: Ranolazine 500mg by mouth twice per day and after two weeks increases 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 therapies but with right ventricular dysfunction (RVEF <45%) will improve their
      health by improving right ventricular (RV) function.
    

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 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

               -  Vasculitis

               -  Metabolic disorder

          -  World Health Organization 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

          -  Pulmonary vascular resistance > 3 mmHg/L/min

          -  Right ventricle ejection fraction < 45%

          -  6-minute walk test distance > 50 meters

        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 chronic 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 systemic hypertension

          -  Implantable cardioverter-defibrillator, Pacemaker, hazardous metallic implants or any
             other contraindication to MRI.