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Targeting the Right Ventricle in Pulmonary Hypertension

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ClinicalTrials.gov Identifier: NCT01839110
Recruitment Status : Active, not recruiting
First Posted : April 24, 2013
Last Update Posted : June 23, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Pulmonary Hypertension Drug: Ranolazine Drug: Placebo

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : July 2013
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Ranolazine
Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day
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.
Other Name: Ranexa
Placebo Comparator: Placebo
Placebo by mouth twice per day
Drug: Placebo
Placebo by mouth twice per day for a total of 26 weeks.
No Intervention: Observational
Patients with pulmonary hypertension who have normal RV function (RVEF >=45%) will undergo same procedures in the observational arm but will not receive an intervention.


Outcome Measures

Primary Outcome Measures :
  1. Number and percentage of subjects with high risk profile at end of the study [ Time Frame: 6 months ]
    Number and percentage of subjects with high risk profile at Week 26. Patients with high risk profile are defined as patients with clinical worsening events or lack of clinical improvement at the end of the study.


Secondary Outcome Measures :
  1. Glucose and lipid metabolites [ Time Frame: baseline ]
    Measure differences in glucose and lipid metabolism in subjects with and without RV dysfunction at baseline.

  2. Changes from baseline in glucose and lipid metabolism [ Time Frame: 6 months ]
    Measure fold changes in glucose and lipid metabolism in subjects with persistent right ventricle dysfunction after treatment with and without ranolazine.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839110


Locations
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63130
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
The Cardiovascular Medical Research and Education Fund
Brigham and Women's Hospital
University of Maryland
Yale University
Washington University School of Medicine
Investigators
Principal Investigator: Yuchi Han, MD University of Pennsylvania
More Information

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01839110     History of Changes
Other Study ID Numbers: 817785
First Posted: April 24, 2013    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017

Keywords provided by University of Pennsylvania:
pulmonary hypertension
right ventricular function
ranolazine

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Ventricular Dysfunction
Ventricular Dysfunction, Right
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Heart Diseases
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action