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Clinical Trial Details

Overview

Research Study Summary

A clinical trial to evaluate treatments using Ranolazine for patients with Angina, Right Ventricular Ischemia or Pulmonary Arterial Hypertension

Research Study Title

Effects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial Hypertension

Purpose

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). For this study, you will be asked to perform several tests in order to determine if your heart function, exercise capacity, chest pain and QOL have improved after 3 months of treatment with ranolazine. Ranolazine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of angina.

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 to 80 Years

Overall Status

Recruiting

Lead Sponsor

Northwestern University

Duration

36 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years to 80 Years

Inclusion criteria:

  1. 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.

  2. Right ventricular dysfunction, defined as RV fractional area change < 32% or RV tricuspid annular plane systolic excursion (TAPSE) < 15 mm.

  3. Symptoms of angina or angina equivalent (exertional dyspnea, exertional epigastric pain, exertional nausea).

  4. New York Heart Association functional class II or III symptoms.

  5. 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.

  6. Age 18-80 years.

Exclusion criteria:

  1. Acute coronary syndrome or coronary revascularization within the prior 3 months.

  2. Patients with unstable angina.

  3. Patients with Class IV congestive heart failure.

  4. Planned revascularization, pacemaker or defibrillator placement during the study period.

  5. Changes in antianginal medical therapy likely to occur during the study period.

  6. Corrected QT interval measurement > 500 ms.

  7. 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.

  8. Patients with known history of hepatic dysfunction.

  9. Current use of strong CYP3A inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir and diltizaem.

  10. Patients with pacemakers, cochlear implants, aneurysm clips, who have worked with metal.

  11. Patients with metallic hardware, implants, or prostheses will consult with the radiologist/cardiologist prior to the study.

  12. Patients with severe or end stage renal disease (an estimated GFR < 30 mL/min/1.73 m).

  13. Women who are pregnant or lactating

  14. Any contraindications for the use of a right heart catheter including, but not limited to:

  15. Pulmonic or tricuspid valve stenosis

  16. Prosthetic pulmonic or tricuspid valve

  17. Right atrial or ventricular masses

  18. Previous pneumonectomy

  19. Risk of severe arrhythmias, including left bundle branch block (LBBB)

  20. Subjects unable to perform cardiopulmonary exercise testing will be excluded (i.e. extensive musculoskeletal disease)

Site Locations (1)

Country State City Zip Facility and Contact
United States Illinois Chicago 60611 Northwestern University
Sanjiv Shah, MD
312-926-2926

Sanjiv Shah, MD
Principal Investigator

NCT ID: NCT01174173

Date Last Changed: June 28, 2012

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