Targeting Right Ventricle in Pulmonary Hypertension Gilead

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ranolazine

Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day

Group Type ACTIVE_COMPARATOR

Ranolazine

Intervention Type 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.

Placebo

Placebo by mouth twice per day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Ranexa

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No