Phase 4
N=22
Targeting Right Ventricle in Pulmonary Hypertension Gilead
Pulmonary Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT02829034 ↗Enrolled (actual)
22
Serious AEs
22.7%
Results posted
Feb 2019
Primary outcome: Primary: Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage) — 7.56; -3.99 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Ranolazine (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage) |
7.56; -3.99 | — |
| SECONDARY Percent Change in 6min-walk-test Distance |
-0.09; -0.06 | — |
| SECONDARY Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) |
-119.72; -287.75 | — |
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.
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 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
- Pulmonary capillary wedge pressure or left ventricular end diastolic pressure 3 mmHg/L/min
- Right ventricle ejection fraction 50 meters
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 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.
Data sourced from ClinicalTrials.gov (NCT02829034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.