Completed

A Randomized, Double-blind, Placebo Controlled, Multi-center Study to Assess the Effect of Ranolazine on Outcomes in Subjects With Pulmonary Hypertension and Right Ventricular Dysfunction Accompanied by a Comparative Study of Cellular Metabolism in Subjects With Pulmonary Hypertension With and Without Right Ventricular Dysfunction

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What is being tested

Ranolazine

+ Placebo

Drug
Who is being recruted

Cardiovascular Diseases+3

+ Hypertension

+ Lung Diseases

From 18 to 80 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 4
Interventional
Study Start: July 2013
See protocol details

Summary

Principal SponsorUniversity of Pennsylvania
Last updated: February 5, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01839110
Principal SponsorUniversity of Pennsylvania
Last updated: February 5, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

22 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHypertensionLung DiseasesRespiratory Tract DiseasesVascular DiseasesHypertension, Pulmonary

Criteria

6 inclusion criteria required to participate
Baseline 6-minute walk test distance > 50 meters
Mean pulmonary artery pressure > 25 mmHg at rest
Pulmonary capillary wedge pressure or left ventricular end diastolic pressure < 15 mmHg
Stable on baseline existing PH specific therapy for 12 weeks with no dosage change within 28 days prior to screening
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7 exclusion criteria prevent from participating
Any family history of corrected QT interval prolongation, congenital long QT syndrome, or receiving drugs that prolong the corrected QT interval
Left sided heart disease including any of the following: moderate or greater aortic or mitral valve disease, Any left ventricle cardiomyopathy, Left ventricular systolic dysfunction defined as an ejection fraction < 50%, Symptomatic coronary artery disease
Parenchymal lung disease showing total lung capacity < 50% of predicted OR forced expiratory volume at one second/forced vital capacity < 50%
Portal hypertension associated with liver disease
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day

Group II

Placebo
Placebo by mouth twice per day

Group III

No Intervention
Patients with pulmonary hypertension who have normal RV function (RVEF &gt;=45%) will undergo same procedures in the observational arm but will not receive an intervention.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

University of Maryland

Baltimore, United StatesOpen University of Maryland in Google Maps

Brigham and Women's Hospital

Boston, United States

University of Pennsylvania

Philadelphia, United States
Completed3 Study Centers