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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):
Duke University
ClinicalTrials.gov Identifier:
NCT01721967
First received: November 2, 2012
Last updated: October 29, 2014
Last verified: October 2014
  Purpose

The purpose of RHYME is to evaluate the safety and efficacy of ranolazine in Hypertrophic Cardiomypathy patients with chest pain or dyspnea 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:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Safety of Ranolazine with regard to QT interval [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
  • Safety of Ranolazine with regard to adverse events [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
  • Safety of Ranolazine with regard to drug tolerability [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in number of episodes of angina per week [ Time Frame: Baseline and 60 Days post treatment ] [ Designated as safety issue: No ]
    Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).

  • Improvement in dyspnea [ Time Frame: Baseline and 60 Days post treatment ] [ Designated as safety issue: No ]
    Efficacy of ranolazine in HCM patients with respect to improvements in dyspnea.

  • Improvement in quality of life [ Time Frame: Baseline and 60 Days post treatment ] [ Designated as safety issue: No ]
    Efficacy of ranolazine in HCM patients with respect to improvement in quality of life evaluation with the Seattle Angina Questionnaire (SAQ) and Kansas City Cardiomyopathy Questionnaire (KCCQ).


Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (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/Shortness of Breath 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Duke University
ClinicalTrials.gov Identifier: NCT01721967     History of Changes
Other Study ID Numbers: Pro00039302, 3938381
Study First Received: November 2, 2012
Last Updated: October 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
chest pain
dyspnea

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

ClinicalTrials.gov processed this record on November 23, 2014