Hypertrophic CardiomyopathyPhase 4RHYMENCT01721967
Ranolazine for the Treatment of Chest Pain in HCM Patients
A Phase 4 study testing Ranolazine in people with Hypertrophic Cardiomyopathy, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- Ranolazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to May 2016
- Phase
- Phase 4
- 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
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: 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).
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- Ranolazine
- Keywords
- chest pain, dyspnea
- Medical subject headings
- Cardiomyopathy, Hypertrophic, Chest Pain, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
| Study group | Role | What they receive |
|---|---|---|
| Ranolazine | Experimental | Ranolazine, 500 mg for 60 days Receives: Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
QT Interval
Measured: 60 Days
Number of Adverse Events Considered Probably or Possibly Related to Study Drug
Number of events that are considered probably or possibly related to study drug.
Measured: 60 Days
Drug Tolerability
Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose
Measured: 60 days
Secondary outcomes (3)
Improvement in Number of Episodes of Angina Per Week
Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).
Measured: Baseline and 60 Days post treatment
Seattle Angina Questionnaire (SAQ)
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.
Measured: 60 Days post treatment
Kansas City Cardiomyopathy Questionnaire (KCCQ)
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
Measured: 60 days post treatement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2015
- Study completionMay 2016
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 Hypertrophic CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01721967
- Sponsor's protocol ID
- Pro00039302
- Other IDs
- 3938381
- Acronym
- RHYME
- Status last verified
- Jan 2017
- First submitted
- 2 Nov 2012
- Last updated
- 3 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation
- ClinicalTrials.gov ID
- NCT01721967
- Acronym / sponsor ID
- RHYME / Pro00039302
- Conditions
- Hypertrophic Cardiomyopathy
- Keywords
- chest pain, dyspnea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Nov 2012 (estimated)
- Results
- Posted 18 Jan 2017
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 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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranolazine | Experimental | Drug: RanolazineRanolazine, 500 mg for 60 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| RanolazineAlso: Ranexa | Drug | Ranolazine |
Primary outcome
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
3 secondary outcomes
Improvement in Number of Episodes of Angina Per Week
Time frame: Baseline and 60 Days post treatment
Seattle Angina Questionnaire (SAQ)
Time frame: 60 Days post treatment
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: 60 days post treatement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranolazine in people with Hypertrophic Cardiomyopathy, run by Duke University 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 4 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: finished, as of the sponsor's last update on 3 Mar 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 18 Jan 2017). 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?
QT Interval (time frame: 60 Days). The study lists 3 primary outcomes in all. 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 3 Mar 2017.