Clinical trial NCT02829034: Targeting Right Ventricle in Pulmonary Hypertension Gilead
Official title: A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Using Cardiovascular MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Hypertension
Keywords: pulmonary hypertension
right ventricular function
ranolazine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
name: University of Maryland
name: Gilead Sciences
First posted: 2016-07-12
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 \< 15 mmHg
* Pulmonary vascular resistance \> 3 mmHg/L/min
* Right ventricle ejection fraction \< 45%
* 6-minute walk test distance \> 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.

Primary outcomes:
measure: Absolute Change From Baseline Right Ventricular Ejection Fraction (the Unit is Percentage)
timeFrame: 26 weeks
Secondary outcomes:
measure: Percent Change in 6min-walk-test Distance
timeFrame: 6 months
measure: Change in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Yuchi Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.