Back to resultsTargeting Right Ventricle in Pulmonary Hypertension Gilead
Primary Purpose
Pulmonary Hypertension
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ranolazine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, right ventricular function, ranolazine
Eligibility 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 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.
Sites / Locations
- University of Maryland
- Brigham and Women's Hospital
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Ranolazine
Placebo
Arm Description
Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day
Placebo by mouth twice per day
Outcomes
Primary Outcome Measures
Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)
Change in right ventricle ejection fraction as assessed by MRI
Secondary Outcome Measures
Percent Change in 6min-walk-test Distance
6-minute walk test
Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
NT-proBNP measured at 6-months compared to baseline
Full Information
NCT ID
NCT02829034
First Posted
July 5, 2016
Last Updated
February 5, 2019
Sponsor
University of Pennsylvania
Collaborators
Brigham and Women's Hospital, University of Maryland, Gilead Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02829034
Brief Title
Targeting Right Ventricle in Pulmonary Hypertension Gilead
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
January 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Brigham and Women's Hospital, University of Maryland, Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, right ventricular function, ranolazine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranolazine
Arm Type
Active Comparator
Arm Description
Ranolazine 500mg by mouth twice per day and after two weeks increase to 1000mg by mouth twice per day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo by mouth twice per day
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Placebo by mouth twice per day for a total of 26 weeks
Primary Outcome Measure Information:
Title
Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)
Description
Change in right ventricle ejection fraction as assessed by MRI
Time Frame
26 weeks
Secondary Outcome Measure Information:
Title
Percent Change in 6min-walk-test Distance
Description
6-minute walk test
Time Frame
6 months
Title
Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
Description
NT-proBNP measured at 6-months compared to baseline
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuchi Han, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29531764
Citation
Han Y, Forfia PR, Vaidya A, Mazurek JA, Park MH, Ramani G, Chan SY, Waxman AB. Rationale and design of the ranolazine PH-RV study: a multicentred randomised and placebo-controlled study of ranolazine to improve RV function in patients with non-group 2 pulmonary hypertension. Open Heart. 2018 Feb 23;5(1):e000736. doi: 10.1136/openhrt-2017-000736. eCollection 2018.
Results Reference
derived
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Targeting Right Ventricle in Pulmonary Hypertension Gilead
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