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

November 2, 2012
October 29, 2014
November 2012
July 2015   (final data collection date for primary outcome measure)
  • 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 ]
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).
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 ] [ 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).
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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.
 
Enrolling by invitation
20
December 2015
July 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01721967
Pro00039302, 3938381
Yes
Duke University
Duke University
Gilead Sciences
Not Provided
Duke University
October 2014

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