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Ranolazine for the Treatment of Chest Pain in HCM Patients (RHYME)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Andrew Wang, Duke University
ClinicalTrials.gov Identifier:
NCT01721967
First received: November 2, 2012
Last updated: April 24, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain despite treatment with standard medical therapy. This is a small, pilot, open-label (non-randomized) study of an approved drug for the treatment of angina in a novel patient population (adult patient population with hypertrophic cardiomyopathy).


Condition Intervention Phase
Hypertrophic Cardiomyopathy
 Drug: Ranolazine
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation

Resource links provided by NLM:

Drug Information available for: Ranolazine
U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Chest Pain [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Following 2 months of therapy with ranolazine, symptomatic patients with Hypertrophic Cardiomyopathy will demonstrate signals of improvement on testing including angina frequency evaluation (number of episodes of angina per week).


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine
Ranolazine, 500 mg for 60 days
 Drug: Ranolazine
Other Name: Ranexa

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Left Ventricle wall thickness >/= 15mm in the absence of other condition causing hypertrophy
  • Baseline Angina Frequency of > 2 episodes per week
  • Willing to provide informed consent

Exclusion Criteria:

  • Severe stenotic valvular disease
  • Severe valvular regurgitation except mitral regurgitation due to systolic anterior motion
  • Significant (>60% stenosis) coronary artery disease
  • Acute coronary syndrome within 30 days
  • Severe heart failure defined as LV systolic dysfunction with Ejection Fraction <40% or NYHA class 4 symptoms
  • Severe renal impairment (glomerular filtration rate, <30 mL/min/1.73 m2)
  • Moderate-severe hepatic impairment (Child-Pugh classes B and C)
  • Hospitalization for cardiac reason within 3 months of enrollment
  • Anticipated changes to treatment of HCM within study period, including medications, device implantation, or septal reduction therapies
  • Concomitant use of ketoconazole, macrolide antibiotics, and HIV protease inhibitors
  • Active myocarditis, pericarditis, or restrictive cardiomyopathy
  • Non-cardiac terminal illness with expected survival less than 6 months
  • Women who are of childbearing potential
  • Inability to perform or adhere to study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721967

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Gilead Sciences
  More Information

No publications provided

Responsible Party: Andrew Wang, MD, Duke University
ClinicalTrials.gov Identifier: NCT01721967     History of Changes
Other Study ID Numbers: Pro00039302, 3938381
Study First Received: November 2, 2012
Last Updated: April 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
chest pain

Additional relevant MeSH terms:
Cardiomyopathy, Hypertrophic
Hypertrophy
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
 Heart Valve Diseases
Pathological Conditions, Anatomical
Ranolazine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013