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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01174173
Date of registration: 23/07/2010
Prospective Registration: Yes
Primary sponsor: Northwestern University
Public title: Ranolazine and Pulmonary Hypertension
Scientific title: Effects of Ranolazine in Patients With Angina Due to Right Ventricular Ischemia in Pulmonary Arterial Hypertension
Date of first enrolment: June 2010
Target sample size: 11
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01174173
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Sanjiv Shah, MD
Address: 
Telephone:
Email:
Affiliation:  Northwestern University
Key inclusion & exclusion criteria

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:

- 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)

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Angina
Pulmonary Arterial Hypertension
Intervention(s)
Drug: Ranolazine
Primary Outcome(s)
6-Minute Walk Test [Time Frame: 3 Months]
Improve Angina Symptoms [Time Frame: 3 months]
Improve Quality of Life [Time Frame: 3 Months]
Secondary Outcome(s)
Absolute RV Longitudinal Strain [Time Frame: 3 months]
Right Ventricular Hemodynamics [Time Frame: 3 months]
RV Perfusion on Cardiac MRI [Time Frame: 3 months]
Secondary ID(s)
STU00030314
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Gilead Sciences
Ethics review
Results
Results available: Yes
Date Posted: 23/04/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01174173
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