Targeting the Right Ventricle in Pulmonary Hypertension

NCT ID: NCT01839110

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-01-31

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.

Conditions

Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ranolazine

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

Group Type: ACTIVE_COMPARATOR

Ranolazine

Intervention Type: DRUG

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.

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.

Observational

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Ranolazine

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

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Ranexa

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cardiovascular Medical Research and Education Fund

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

University of Maryland

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuchi Han, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Maryland

Baltimore, Maryland, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 29531764 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

817785

Identifier Type: -

Identifier Source: org_study_id