Ranolazine for the Treatment of Chest Pain in HCM Patients (RHYME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01721967|
Recruitment Status : Completed
First Posted : November 6, 2012
Results First Posted : January 18, 2017
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hypertrophic Cardiomyopathy||Drug: Ranolazine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||May 2016|
U.S. FDA Resources
Ranolazine, 500 mg for 60 days
Other Name: Ranexa
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01721967
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|