Targeting Right Ventricle in Pulmonary Hypertension Gilead



Status:Completed
Conditions:High Blood Pressure (Hypertension), High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 80
Updated:2/28/2019
Start Date:July 2016
End Date:January 2018

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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

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.


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.
We found this trial at
3
sites
75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Baltimore, MD
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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