Targeting the Right Ventricle in Pulmonary Hypertension

NCT01839110 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 817785
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 3

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

Keywords

pulmonary hypertension; right ventricular function; ranolazine

Outcome Measures

Primary Outcomes (1)

• Changes in Right Ventricular Ejection Fraction

  right ventricular ejection fraction by cardiac MRI

  6 months

Study Arms (3)

Ranolazine

ACTIVE COMPARATOR

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

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Placebo by mouth twice per day

Drug: Placebo

Observational

NO INTERVENTION

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.

Interventions

Ranolazine 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.

Also known as: Ranexa

Ranolazine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pennsylvania: lead
• The Cardiovascular Medical Research and Education Fund: collaborator
• Brigham and Women's Hospital: collaborator
• University of Maryland: collaborator
• Yale University: collaborator
• Washington University School of Medicine: collaborator

Study Sites (3)

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 29531764 DERIVED

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Yuchi Han
• Organization: University of Pennsylvania

yuchi.han@uphs.upenn.edu

215-662-2855

Study Officials

• Yuchi Han, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2013
• First Posted: April 24, 2013
• Study Start: July 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: February 5, 2019
• Results First Posted: December 19, 2018

Record last verified: 2018-11

Locations

US (3)