The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure (RAD HF)

This study has been terminated.
(Difficultly in enrolling)
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier:
NCT01887353
First received: June 24, 2013
Last updated: July 15, 2015
Last verified: April 2015
Results First Received: April 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Atrial Fibrillation
Heart Failure
Interventions: Drug: Ranolazine
Drug: Placebo

  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: Patients will take ranolazine 1000 mg tablets twice daily
Placebo Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.

Participant Flow:   Overall Study
    Ranolazine     Placebo  
STARTED     4     4  
COMPLETED     0 [1]   1 [1]
NOT COMPLETED     4     3  
Study stopped early                 4                 3  
[1] Study was stopped early because of difficulty recruiting.



  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.
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Reporting Groups
  Description
Ranolazine Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
Placebo Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
Total Total of all reporting groups

Baseline Measures
    Ranolazine     Placebo     Total  
Number of Participants  
[units: participants]
  4     4     8  
Age  
[units: years]
Mean (Standard Deviation)
  89.7  (9.5)     78.9  (8.9)     84.3  (9.2)  
Gender  
[units: participants]
     
Female     3     2     5  
Male     1     2     3  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     4     4     8  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     4     4     8  



  Outcome Measures

1.  Primary:   Time to First Atrial Fibrillation (AF) Recurrence   [ Time Frame: up to 6 months ]


  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: T. Jared Bunch
Organization: Intermountain Healthcare
phone: 8015074701
e-mail: jared.bunch@imail.org



Responsible Party: Intermountain Health Care, Inc.
ClinicalTrials.gov Identifier: NCT01887353     History of Changes
Other Study ID Numbers: 1024475
Study First Received: June 24, 2013
Results First Received: April 9, 2015
Last Updated: July 15, 2015
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board