Status:
COMPLETED
Ranolazine and Pulmonary Hypertension
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Gilead Sciences
Conditions:
Angina
Pulmonary Arterial Hypertension
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of the study is to determine if the medication, ranolazine (study drug), can help improve blood flow to your heart, increase your exercise capacity and improve your quality of life (QOL). ...
Detailed Description
This study is looking to enroll patients with pulmonary hypertension (PH). PH is abnormally high blood pressure in the arteries of the lungs. It makes the right side of the heart need to work harder t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- World Health Organization (WHO) Group 1 PAH, defined as a pulmonary hypertension with mean pulmonary artery pressure \> 25 mmHg, pulmonary capillary wedge pressure \< 15 mmHg, and pulmonary vascular resistance \> 3 Wood units.
- Right ventricular dysfunction, defined as RV fractional area change \< 32% or RV tricuspid annular plane systolic excursion (TAPSE) \< 15 mm.
- Symptoms of angina or angina equivalent (exertional dyspnea, exertional epigastric pain, exertional nausea).
- New York Heart Association functional class II or III symptoms.
- Stable doses of pulmonary vasodilators (prostacyclins, endothelin receptor antagonists, phosphodiesterase inhibitors), with no new therapy initiation or dose escalation \> 50% in the 4 weeks prior to randomization.
- Age 18-80 years.
- Exclusion criteria:
- Acute coronary syndrome or coronary revascularization within the prior 3 months.
- Patients with unstable angina.
- Patients with Class IV congestive heart failure.
- Planned revascularization, pacemaker or defibrillator placement during the study period.
- Changes in antianginal medical therapy likely to occur during the study period.
- Corrected QT interval measurement \>500 ms.
- Patients with pre-existing QT prolongation (including congenital long QT syndrome) or receiving other QT prolonging drugs (including Class Ia-e.g., quinidine, Class III-e.g., dofetilide, sotalol, antiarrhythmics; antipsychotics (e.g., thioridazine, ziprasidone), or known history of complex ventricular arrhythmias requiring antiarrhythmic medications or ICD implantation.
- Patients with known history of hepatic dysfunction.
- Current use of strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir and diltizaem.
- Patients with pacemakers, cochlear implants, aneurysm clips, who have worked with metal.
- Patients with metallic hardware, implants, or prostheses will consult with the radiologist/cardiologist prior to the study.
- Patients with severe or end stage renal disease (an estimated GFR \< 30 mL/min/1.73 m).
- Women who are pregnant or lactating
- Any contraindications for the use of a right heart catheter including, but not limited to:
- Pulmonic or tricuspid valve stenosis
- Prosthetic pulmonic or tricuspid valve
- Right atrial or ventricular masses
- Previous pneumonectomy
- Risk of severe arrhythmias, including left bundle branch block (LBBB)
- Subjects unable to perform cardiopulmonary exercise testing will be excluded (i.e. extensive musculoskeletal disease)
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT01174173
Start Date
June 1 2010
End Date
October 1 2014
Last Update
May 11 2018
Active Locations (1)
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1
Northwestern University
Chicago, Illinois, United States, 60611