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

This study has been completed.
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01721967
First received: November 2, 2012
Last updated: January 19, 2017
Last verified: January 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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:
  • QT Interval [ Time Frame: 60 Days ]
  • Number of Adverse Events Considered Probably or Possibly Related to Study Drug [ Time Frame: 60 Days ]
    Number of events that are considered probably or possibly related to study drug.

  • Drug Tolerability [ Time Frame: 60 days ]
    Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose


Secondary Outcome Measures:
  • Improvement in Number of Episodes of Angina Per Week [ Time Frame: Baseline and 60 Days post treatment ]
    Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).

  • Seattle Angina Questionnaire (SAQ) [ Time Frame: 60 Days post treatment ]
    The Seattle Angina Questionnaire (SAQ) is a self-administered, 19-item questionnaire, a cardiac disease-related quality-of-life measure. The SAQ is well validated and sensitive to clinical changes. It has five subscales: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. The possible range of scores for each of the five subscales is 0 to 100, with higher scores indicating better quality of life.

  • Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 60 days post treatement ]
    Kansas City Cardiomyopathy Questionnaire (KCCQ) (scores range from 0 to 100 with higher scores representative of a higher quality of life; clinically important changes are considered > 10 points and >5 points, respectively, as previously established


Enrollment: 14
Study Start Date: November 2012
Study Completion Date: May 2016
Primary Completion Date: November 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   (Adult, Senior)
Sexes Eligible for Study:   All
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

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01721967     History of Changes
Other Study ID Numbers: Pro00039302
3938381 ( Other Identifier: Duke University )
Study First Received: November 2, 2012
Results First Received: November 4, 2016
Last Updated: January 19, 2017

Keywords provided by Duke University:
chest pain
dyspnea

Additional relevant MeSH terms:
Cardiomyopathies
Hypertrophy
Cardiomyopathy, Hypertrophic
Heart Diseases
Cardiovascular Diseases
Pathological Conditions, Anatomical
Aortic Stenosis, Subvalvular
Aortic Valve Stenosis
Heart Valve Diseases
Ranolazine
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 21, 2017