Targeting Right Ventricle in Pulmonary Hypertension Gilead

NCT02829034 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 824808
• 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 therapies but with right ventricular dysfunction (RVEF \<45%) will improve their health by improving right ventricular (RV) function.

Conditions

Pulmonary Hypertension

Keywords

pulmonary hypertension; right ventricular function; ranolazine

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)

  Change in right ventricle ejection fraction as assessed by MRI

  26 weeks

Secondary Outcomes (2)

• Percent Change in 6min-walk-test Distance

  6 months

• Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)

  6 months

Study Arms (2)

Ranolazine

ACTIVE COMPARATOR

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

Drug: Ranolazine

Placebo

PLACEBO COMPARATOR

Placebo by mouth twice per day

Drug: Placebo

Interventions

Ranolazine DRUG

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.

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 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

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 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Brigham and Women's Hospital: collaborator
• University of Maryland: collaborator
• Gilead Sciences: 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: Yuchi Han, PI of the study
• Organization: University of Pennsylvania

yuchi.han@uphs.upenn.edu

215-615-3417

Study Officials

• Yuchi Han, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 5, 2016
• First Posted: July 12, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: February 26, 2019
• Results First Posted: February 26, 2019

Record last verified: 2019-02

Locations

US (3)