Ranolazine and Pulmonary Hypertension

Last updated: April 10, 2018
Sponsor: Northwestern University
Overall Status: Completed

Phase

3

Condition

Angina

Acute Pain

Coronary Artery Disease

Treatment

N/A

Clinical Study ID

NCT01174173
STU00030314
  • Ages 18-80
  • All Genders

Study 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). 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. World Health Organization (WHO) Group 1 PAH, defined as a pulmonary hypertension withmean pulmonary artery pressure > 25 mmHg, pulmonary capillary wedge pressure < 15mmHg, and pulmonary vascular resistance > 3 Wood units.

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

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

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

  5. Stable doses of pulmonary vasodilators (prostacyclins, endothelin receptorantagonists, phosphodiesterase inhibitors), with no new therapy initiation or doseescalation > 50% in the 4 weeks prior to randomization.

  6. Age 18-80 years.

Exclusion

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 studyperiod.

  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) orreceiving other QT prolonging drugs (including Class Ia—e.g., quinidine, ClassIII—e.g., dofetilide, sotalol, antiarrhythmics; antipsychotics (e.g., thioridazine,ziprasidone), or known history of complex ventricular arrhythmias requiringantiarrhythmic 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 anddiltizaem.

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

  11. Patients with metallic hardware, implants, or prostheses will consult with theradiologist/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 limitedto:

  • 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)

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

Study Design

Total Participants: 11
Study Start date:
June 01, 2010
Estimated Completion Date:
October 31, 2014

Study 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 than normal and is usually caused by a narrowing of the small arteries of the lung. This narrowing makes it harder for the right side of the heart to circulate the blood to the lungs. Over time, the right side of the heart may become enlarged and symptoms (such as angina [chest pain] shortness of breath, fatigue, edema) begin to appear.

Ranolazine is a safe, well-tolerated, and FDA-approved medication for the treatment of chronic stable angina. Ranolazine may potentially improve blood flow to the right ventricle (RV), thereby relieving angina while simultaneously improving RV performance and contractility. This latter effect may increase stroke volume and cardiac output which could translate into benefits in exercise capacity and improved quality of life.

The purpose of this single center, non-randomized, prospective pilot study is to investigate the effects of 3 months treatment with ranolazine on pulmonary artery hemodynamics, exercise capacity and quality of life in patients with PAH and symptoms of angina or angina equivalent.

Connect with a study center

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.