Targeting Right Ventricle in Pulmonary Hypertension Gilead

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Pulmonary Hypertension

Treatments: Drug: Ranolazine; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02829034

824808

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

Ranolazine

Active Comparator group

Description:

Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day

Treatment:

Drug: Ranolazine

Placebo

Placebo Comparator group

Description:

Placebo by mouth twice per day

Treatment:

Drug: Placebo