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Targeting the Right Ventricle in Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Ranolazine

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, right ventricular function, ranolazine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Maryland
Brigham and Women's Hospital
University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Ranolazine

Placebo

Observational

Arm Description

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

Placebo by mouth twice per day

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.

Outcomes

Primary Outcome Measures

Changes in Right Ventricular Ejection Fraction

right ventricular ejection fraction by cardiac MRI

Secondary Outcome Measures

Full Information

NCT ID

NCT01839110

First Posted

April 17, 2013

Last Updated

January 14, 2019

Sponsor

University of Pennsylvania

Collaborators

The Cardiovascular Medical Research and Education Fund, Brigham and Women's Hospital, University of Maryland, Yale University, Washington University School of Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01839110

Brief Title

Targeting the Right Ventricle in Pulmonary Hypertension

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 Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

July 2013 (Actual)

Primary Completion Date

January 2018 (Actual)

Study Completion Date

January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

Collaborators

The Cardiovascular Medical Research and Education Fund, Brigham and Women's Hospital, University of Maryland, Yale University, Washington University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo by mouth twice per day

Arm Title

Observational

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Ranolazine

Other Intervention Name(s)

Ranexa

Intervention Description

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.

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

Changes in Right Ventricular Ejection Fraction

Description

right ventricular ejection fraction by cardiac MRI

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

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 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

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

IPD Sharing Plan Description

IPD available upon request

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 the Right Ventricle in Pulmonary Hypertension

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