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Targeting the Right Ventricle in Pulmonary Hypertension

NCT01839110 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2019-02-05

Study results available
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Summary

This study is looking to see if giving ranolazine to subjects on stable pulmonary hypertension specific therapies but with right ventricular dysfunction (RVEF \<45%) would improve their outcome. This study is accompanied by a baseline comparison of the metabolic profiling/microRNA/iPS cells of subjects with and without right ventricular dysfunction.

Conditions

  • Pulmonary Hypertension

Interventions

DRUG

Ranolazine

Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.

DRUG

Placebo

Placebo by mouth twice per day for a total of 26 weeks.

Sponsors & Collaborators

  • The Cardiovascular Medical Research and Education Fund

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • University of Maryland

    collaborator OTHER

  • Yale University

    collaborator OTHER

  • Washington University School of Medicine

    collaborator OTHER

  • University of Pennsylvania

    lead OTHER

Principal Investigators

  • Yuchi Han, MD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2018-01-31
Completion
2018-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01839110 on ClinicalTrials.gov