Phase 3
N=11
Ranolazine and Pulmonary Hypertension
Angina · Pulmonary Arterial Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01174173 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Apr 2015
Primary outcome: Primary: Improve Angina Symptoms — 1.75 units on a scale — p=0.0013
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ranolazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jan 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improve Angina Symptoms |
1.75 | 0.0013 sig |
| PRIMARY 6-Minute Walk Test |
419 | 0.09 |
| PRIMARY Improve Quality of Life |
60.3; 64.2 | 0.37 |
| SECONDARY RV Perfusion on Cardiac MRI |
— | — |
| SECONDARY Absolute RV Longitudinal Strain |
-1.4; 1.0 | 0.037 sig |
| SECONDARY Right Ventricular Hemodynamics |
48 | 0.66 |
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 criteria
- World Health Organization (WHO) Group 1 PAH, defined as a pulmonary hypertension with mean pulmonary artery pressure > 25 mmHg, pulmonary capillary wedge pressure 3 Wood units.
- Right ventricular dysfunction, defined as RV fractional area change 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)
Data sourced from ClinicalTrials.gov (NCT01174173). 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.