Atrial FibrillationPhase 2RAD HFNCT01887353
The Use of Ranolazine for Atrial Fibrillation and Diastolic Heart Failure
A Phase 2 study testing Ranolazine in people with Atrial Fibrillation and Heart Failure, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Feb 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or non-pregnant female > 18 years of age;
- Documentation of heart failure and who are in NYHA class II or III;
- Documented history of symptomatic AF < 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
- Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
- Demonstration of preserved ejection fraction (EF) by echocardiography;
- Echocardiographic evidence of impaired diastolic filling.
Who cannot join
- Known history of permanent or long-standing AF (> 6 months);
- Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
- Known history of cirrhosis;
- NYHA Class IV;
- Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
- Percutaneous coronary intervention (PCI) within 4 weeks prior to screening, if these patients need to be placed on rivaroxaban or dabigatran post-cardioversion;
Show all 14Show fewer
- Clinically significant valvular disease;
- Clinically significant pulmonary disease;
- Stroke within 3 months prior to screening;
- Creatinine clearance < 30 mL/min as calculated by Cockcroft-Gault formula;
- Use of anti-arrhythmic drugs (Class Ia or IIIc) within 3 months prior to screening;
- Concurrent use of drugs considered strong inhibitors of CYP3A;
- Concurrent use of drugs considered as CYP3A inducers;
- Prior treatment with ranolazine.
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Medical Center
Murray, Utah, 84107-5701
About this study
Official title: A Randomized, Double-blind, Placebo Controlled Study, Designed to Investigate the Effect of Ranolazine on Left Ventricular Diastolic Function in Patients With Symptomatic AF and Preserved Ejection Function, After the Subject Has Undergone a Successful External Electrical Cardioversion
The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- Ranolazine, Placebo
- Keywords
- atrial fibrillation, heart failure, ranolazine, cardioversion, persistent AF, paroxysmal AF
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Patients will take ranolazine 1000 mg tablets twice daily
PlaceboDrug
Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Active comparator | Not described Receives: Drug: Ranolazine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Atrial Fibrillation (AF) Recurrence
There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Difficultly in enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- T. Jared Bunch, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01887353
- Sponsor's protocol ID
- 1024475
- Acronym
- RAD HF
- Status last verified
- Apr 2015
- First submitted
- 24 Jun 2013
- Last updated
- 20 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo Controlled Study, Designed to Investigate the Effect of Ranolazine on Left Ventricular Diastolic Function in Patients With Symptomatic AF and Preserved Ejection Function, After the Subject Has Undergone a Successful External Electrical Cardioversion
- ClinicalTrials.gov ID
- NCT01887353
- Acronym / sponsor ID
- RAD HF / 1024475
- Conditions
- Atrial Fibrillation, Heart Failure
- Keywords
- atrial fibrillation, heart failure, ranolazine, cardioversion, persistent AF, paroxysmal AF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficultly in enrolling
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Jun 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Jun 2013 (estimated)
- Results
- Posted 20 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy of ranolazine in the prevention of recurrent atrial fibrillation in post-cardioversion patients with heart failure and preserved ejection fraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Active comparator | Drug: Ranolazine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or non-pregnant female > 18 years of age;
- Documentation of heart failure and who are in NYHA class II or III;
- Documented history of symptomatic AF < 6 months in duration at the time of presentation, currently in AF at the time of the external electrical cardioversion, and successfully restored to normal sinus rhythm;
- Percutaneous coronary intervention (PCI) patients who can be placed on anticoagulation with warfarin post-cardioversion (and not on rivaroxaban or dabigatran);
- Demonstration of preserved ejection fraction (EF) by echocardiography;
Key exclusion criteria (14 listed)
- Known history of permanent or long-standing AF (> 6 months);
- Other acutely reversible causes of AF, including but not limited to: hyperthyroidism, pericarditis, myocarditis or pulmonary embolism;
- Known history of cirrhosis;
- NYHA Class IV;
- Myocardial Infarction, unstable angina, or coronary artery bypass graft surgery within three months prior to screening;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazinePatients will take ranolazine 1000 mg tablets twice daily | Drug | Ranolazine |
| PlaceboPlacebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day. | Drug | Placebo |
Primary outcome
Time to First Atrial Fibrillation (AF) Recurrence
Time frame: up to 6 months
There were too few participants for an assessment of time to first recurrence, therefore the numbers of participants with recurrence up to 6 months is reported instead
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
T. Jared Bunch, MD principal investigator
Intermountain Health Care, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranolazine in people with Atrial Fibrillation and Heart Failure, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Atrial Fibrillation (AF) Recurrence (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2015.