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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
Results First Received: November 4, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition: Hypertrophic Cardiomyopathy
Intervention: Drug: Ranolazine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ranolazine Ranolazine, 500 mg for 60 days

Participant Flow:   Overall Study
    Ranolazine
STARTED   14 
COMPLETED   11 
NOT COMPLETED   3 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ranolazine Ranolazine, 500 mg for 60 days

Baseline Measures
   Ranolazine 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.2  (9.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      8  57.1% 
Male      6  42.9% 
Seattle Angina Questionnaire [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Physical limitation   49.6  (18.7) 
Anginal stability   45.5  (27.0) 
Anginal frequency   65.5  (13.4) 
Treatment satisfaction   85.2  (12.6) 
Quality of life   40.9  (24.6) 
[1] The SAQ is a self-report instrument with 19 items that yields five subscale scores: 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) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 
Physical limitation   61.7  (20.6) 
Symptom stability   43.2  (16.2) 
Symptom frequency   56.4  (20.6) 
Symptom burden   55.3  (29.4) 
Total symptom score   55.9  (24.2) 
Self-efficacy   78.4  (21.7) 
Quality of life   39.4  (26.6) 
Social limitation   46.0  (31.5) 
Overall summary   51.2  (22.3) 
Clinical summary   58.8  (20.9) 
[1] Similarly, the Kansas City Cardiomyopathy Questionnaire (KCCQ) is a new, self-administered, 23-item questionnaire developed to provide a better description of health-related quality of life in patients with heart failure. It quantifies, in a disease-specific fashion, physical limitation, symptoms (frequency, severity and recent change over time), quality of life, social interference and self-efficacy. All categories of questions are scored from 0-100, with higher number indicating better health.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   QT Interval   [ Time Frame: 60 Days ]

2.  Primary:   Number of Adverse Events Considered Probably or Possibly Related to Study Drug   [ Time Frame: 60 Days ]

3.  Primary:   Drug Tolerability   [ Time Frame: 60 days ]

4.  Secondary:   Improvement in Number of Episodes of Angina Per Week   [ Time Frame: Baseline and 60 Days post treatment ]

5.  Secondary:   Seattle Angina Questionnaire (SAQ)   [ Time Frame: 60 Days post treatment ]

6.  Secondary:   Kansas City Cardiomyopathy Questionnaire (KCCQ)   [ Time Frame: 60 days post treatement ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Andrew Wang, MD
Organization: Duke University Health System
phone: 919-681-6197
e-mail: a.wang@duke.edu



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