Targeting the Right Ventricle in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839110
• Other study ID #: 817785
• Status: Completed
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: January 2018

Study information

• Verified date: November 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Drug:
• Ranolazine
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
Placebo by mouth twice per day for a total of 26 weeks.

Locations

Country	Name	City	State
United States	University of Maryland	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
University of Pennsylvania	Brigham and Women's Hospital, The Cardiovascular Medical Research and Education Fund, University of Maryland, Washington University School of Medicine, Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Right Ventricular Ejection Fraction	right ventricular ejection fraction by cardiac MRI	6 months