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Clinical Trials/NCT02829034
NCT02829034CompletedPhase 4

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

University of Pennsylvania3 sites in 1 country22 target enrollmentStarted: July 2016Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
22
Locations
3
Primary Endpoint
Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Ranolazine

Active Comparator

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

Intervention: Ranolazine (Drug)

Placebo

Placebo Comparator

Placebo by mouth twice per day

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

  • Percent Change in 6min-walk-test Distance(6 months)
  • Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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