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OpenTrials
Completed

NCT Number: NCT02829034

Targeting Right Ventricle in Pulmonary Hypertension Gilead

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Maryland, Baltimore, Maryland, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ranolazine

Drug

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.

Other names: Ranexa

Placebo

Drug

Placebo by mouth twice per day for a total of 26 weeks

Primary outcomes

  1. Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)

    Time frame: 26 weeks

    Change in right ventricle ejection fraction as assessed by MRI

Secondary outcomes

  1. Percent Change in 6min-walk-test Distance

    Time frame: 6 months

    6-minute walk test

  2. Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)

    Time frame: 6 months

    NT-proBNP measured at 6-months compared to baseline

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Brigham and Women's Hospital
  • Gilead Sciences
  • University of Maryland

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 12, 2016
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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