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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
November 2, 2012
January 19, 2017
November 2012
November 2015   (Final data collection date for primary outcome measure)
  • 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
Chest Pain [ Time Frame: 60 Days ]
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).
Complete list of historical versions of study NCT01721967 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Ranolazine for the Treatment of Chest Pain in HCM Patients
Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation
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).
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Supportive Care
Hypertrophic Cardiomyopathy
Drug: Ranolazine
Other Name: Ranexa
Experimental: Ranolazine
Ranolazine, 500 mg for 60 days
Intervention: Drug: Ranolazine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
May 2016
November 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01721967
Pro00039302
3938381 ( Other Identifier: Duke University )
Yes
Not Provided
Not Provided
Duke University
Duke University
Gilead Sciences
Not Provided
Duke University
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP