Targeting Right Ventricle in Pulmonary Hypertension Gilead

Pulmonary Hypertension Clinical Trial

Official title:

A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Using Cardiovascular MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829034
• Other study ID #: 824808
• Status: Completed
• Phase: Phase 4
• Start date: July 2016
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• 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 therapies but with right ventricular dysfunction (RVEF <45%) will improve their health by improving right ventricular (RV) function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• 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 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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Drug:
• Ranolazine
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
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 (4)

Lead Sponsor	Collaborator
University of Pennsylvania	Brigham and Women's Hospital, Gilead Sciences, University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)	Change in right ventricle ejection fraction as assessed by MRI	26 weeks
Secondary	Percent Change in 6min-walk-test Distance	6-minute walk test	6 months
Secondary	Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)	NT-proBNP measured at 6-months compared to baseline	6 months