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Targeting the Right Ventricle in Pulmonary Hypertension

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Pennsylvania
Sponsor:
Collaborators:
The Cardiovascular Medical Research and Education Fund
Brigham and Women's Hospital
University of Maryland
Yale University
Information provided by (Responsible Party):
Yuchi Han, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01839110
First received: April 17, 2013
Last updated: February 20, 2014
Last verified: February 2014

April 17, 2013
February 20, 2014
July 2013
September 2015   (final data collection date for primary outcome measure)
Number and percentage of subjects with high risk profile at end of the study [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number and percentage of subjects with high risk profile at Week 26. Patients with high risk profile are defined as patients with clinical worsening events or lack of clinical improvement at the end of the study.
Time to clinical worsening events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Time to hospitalization for pulmonary hypertension, death, addition of any new type of chronic treatment for worsening pulmonary hypertension, need for lung or heart-lung transplantation, atrial septostomy or other interventional procedure specifically for right heartfailure or pulmonary hypertension, decline of 6-minute walk distance by 10%, increase in Borg Dyspnea Index by 20%, increase in WHO-functional class by 1 or more.
Complete list of historical versions of study NCT01839110 on ClinicalTrials.gov Archive Site
  • Glucose and lipid metabolites [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Measure differences in glucose and lipid metabolism in subjects with and without RV dysfunction at baseline.
  • Changes from baseline in glucose and lipid metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure fold changes in glucose and lipid metabolism in subjects with persistent right ventricle dysfunction after treatment with and without ranolazine.
  • Glucose and lipid metabolites [ Time Frame: baseline ] [ Designated as safety issue: No ]
    Measure differences in glucose and lipid metabolitis in subjects with and without RV dysfunction at baseline.
  • Changes from baseline in glucose and lipid metabolism [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Measure fold changes in glucose and lipid metabolism in subjects with persistent right ventricle dysfunction after treatment with and without ranolazine.
Not Provided
Not Provided
 
Targeting the Right Ventricle in Pulmonary Hypertension
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

This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF <=40%) 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pulmonary Hypertension
  • Drug: 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.
    Other Name: Ranexa
  • Drug: Placebo
    Placebo by mouth twice per day for a total of 26 weeks.
  • Active Comparator: Ranolazine
    Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day
    Intervention: Drug: Ranolazine
  • Placebo Comparator: Placebo
    Placebo by mouth twice per day
    Intervention: Drug: Placebo
  • No Intervention: Observational
    Patients with pulmonary hypertension who have near normal RV function (RVEF >40%) will undergo same procedures in the observational arm but will not receive an intervention.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
September 2015
September 2015   (final data collection date for primary outcome measure)

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, simple congenital such as repaired atrial or ventricular septal defect or unrepaired small atrial or ventricular septal defect with persistent and out of proportion pulmonary arterial hypertension
  • 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
  • Untreated severe obstructive sleep apnea
  • 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
  • Moderate to severe chronic renal disease
Both
18 Years to 80 Years
No
Contact: Yuchi Han, MD 215-662-2855 yuchi.han@uphs.upenn.edu
Contact: Amanda Baer, MB, MBA 215-746-3423 baer2@mail.med.upenn.edu
United States
 
NCT01839110
817785
Yes
Yuchi Han, University of Pennsylvania
University of Pennsylvania
  • The Cardiovascular Medical Research and Education Fund
  • Brigham and Women's Hospital
  • University of Maryland
  • Yale University
Principal Investigator: Yuchi Han, MD University of Pennsylvania
University of Pennsylvania
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP