Ranolazine and Pulmonary Hypertension

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.

Timeline

Start

2010-06

Primary completion

2014-01

Completion

2014-10

Outcome

Mixed primary results

paper After 3 months, ranolazine administration was safe and associated with improvement in functional class (P = 0.0013) PMID 26401256 ↗

registry analysis (superiority or other test); Ranolazine; p = 0.09; t-test, 2 sided NCT01174173 ↗

registry analysis (superiority or other test); Ranolazine; p = 0.37; t-test, 2 sided NCT01174173 ↗

Publications

• Khan SS, Cuttica MJ, Beussink-Nelson L, Kozyleva A, Sanchez C, Mkrdichian H, Selvaraj S, Dematte JE, Lee DC, Shah SJ. Effects of ranolazine on exercise capacity, right ventricular indices, and hemodynamic characteristics in pulmonary arterial hypertension: a pilot study. Pulm Circ. 2015 Sep;5(3):547-56. doi: 10.1086/682427.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranolazine	Small molecule	1000 mg	Oral

Indications