CardiomyopathyPhase 4NCT01345188

Ranolazine in Ischemic Cardiomyopathy

A Phase 4 study testing Ranexa in people with Cardiomyopathy and Chest Pain, run by Midwest Cardiovascular Research Foundation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Patients with ischemic cardiomyopathy may continue to experience persistent chest pain and shortness of breath despite conventional medical therapy and/or revascularization. The purpose of this study is to determine the efficacy of taking Ranexa versus placebo in patients with ischemic (due to blockages)… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiomyopathy, Chest Pain, Dyspnea
What is being tested?: Ranexa
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Apr 2011to Apr 2014
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

Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
Anginal chest pain or dyspnea
Documentation of non treatable or optimally treated coronary artery disease
Ejection Fraction of less than or equal to 40%

Who cannot join

Less than 18 years of age
Pregnant or breast feeding
Patients with non ischemic cardiomyopathy

Trial locations and contacts

1 site in 1 country.

United States1 site

Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803

Other trials in United States

About this study

Official title: Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study

Conditions: Cardiomyopathy, Chest Pain, Dyspnea
Being tested: Ranexa, Placebo
Medical subject headings: Cardiomyopathies, Chest Pain, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RanexaDrug
Also called Ranolazine
1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
PlaceboDrug
1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Study groups in NCT01345188
Study group	Role	What they receive
Ranolazine	Active comparator	1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. Receives: Drug: Ranexa
Placebo	Placebo comparator	1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Anginal Frequency
Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.
Measured: 12 weeks
Quality of Life Questionnaire
Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life.
These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety.
Measured: 12 weeks
Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)
RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Apr 2014

First posted29 Apr 2011 (estimated)
Study startApr 2011
Primary completionApr 2014
Study completionApr 2014

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 CardiomyopathyStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01345188
Sponsor's protocol ID: IN-US-259-D032
Status last verified: Nov 2024
First submitted: 28 Apr 2011
Last updated: 9 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
ClinicalTrials.gov ID: NCT01345188
Acronym / sponsor ID: IN-US-259-D032
Conditions: Cardiomyopathy, Chest Pain, Dyspnea
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Midwest Cardiovascular Research FoundationUniversity, hospital or other
Collaborators: Gilead Sciences
Study start: Apr 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 29 Apr 2011 (estimated)
Results: Posted 6 Sep 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Ranolazine	Active comparator	Drug: Ranexa1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
Placebo	Placebo comparator	Drug: Placebo1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ischemic cardiomyopathy patients on optimal medical treatment. Optimal medical treatment is defined as the continued symptoms of chest pain or dyspnea despite treatment with 2 antiischemic agents (beta blockers, CCB or nitrates). Unless contraindicated, all cardiomyopathy patients should be treated with a beta blocker and an ACEI/ARB.
Anginal chest pain or dyspnea
Documentation of non treatable or optimally treated coronary artery disease
Ejection Fraction of less than or equal to 40%

Key exclusion criteria (3 listed)

Less than 18 years of age
Pregnant or breast feeding
Patients with non ischemic cardiomyopathy

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
RanexaAlso: Ranolazine1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug	Ranolazine
Placebo1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug	Placebo

Primary outcome

Anginal Frequency
Time frame: 12 weeks
Anginal frequency as assessed by Seattle Angina Questionnaire. Scoring is done by assessing responses on an ordinal value. Anginal score is scored by the patient by selecting a number from 0 to 100 with low score indicates more anginal frequency. The mean of the the scores of all patients analyzed were compared between placebo and Ranolazine.
Quality of Life Questionnaire
Time frame: 12 weeks
Quality of life as measured by the Seattle Angina Questionnaire as a score ranging from 0 to 100. Higher score indicates better quality of life. The Qaulity of life is scored by the patient. It assesses the perceived satisfaction or dissatisfaction in the major domains of life. These include mobility, self-care, Usual activities (leisure, work, family), Pain/Discomfort, and Anxiety.
Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)
Time frame: 12 weeks
RDQ is a four item questionnaire that evaluates a patient's dyspnea with regular activity. Each question answered postiviely is given a score of 1. Total score possible is 4. A higher score indicates worse dyspnea. A difference between the score at end of treatment minus baseline is performed. A negative score indicates improvement. Comparing the difference between the 2 arms (placebo and ranolazine) is performed.

Results and safety

Results posted to the registry on 6 Sep 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ranolazine, Then Placebo	28	26

Primary outcome: Anginal Frequency

Time frame: 12 weeks. Mean (Full Range). Unit: units on a scale

Measure	Ranolazine n = 24	Placebo n = 24
Value	86.67 (40 to 100)	74.44 (10 to 100)

Ranolazine vs Placebo: p = 0.058, Paired t test

Population analysed: Patients receiving ranolazine for 6 weeks and crossed over to placebo or vice versa. Higher number on the angina scale indicates less angina

Primary outcome: Quality of Life Questionnaire

Time frame: 12 weeks. Mean (Full Range). Unit: units on a scale

Measure	Ranolazine n = 24	Placebo n = 24
Value	72.22 (50 to 92)	66.67 (42 to 92)

Ranolazine vs Placebo: p = 0.048, Paired t test

Primary outcome: Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)

Time frame: 12 weeks. Mean (Full Range). Unit: units on a scale

Measure	Ranolazine n = 20	Placebo n = 20
Value	-0.45 (-4 to 2)	-0.34 (-2 to 1)

Ranolazine vs Placebo: p >0.05, Wilcoxon Signed rank

Population analysed: Patients with dsypnea. The score reflects difference between baseline and following treatment with ranolazine or placebo

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ranolazine	2 of 24 (8.3%)	6 of 24 (25%)	0 of 24
Placebo	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Cardiomyopathy

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NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
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Not yet recruitingObservational study
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RecruitingObservational study
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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.

Nicolas W Shammas, MD principal investigator

Midwest Cardiovascular Research Foundation

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 Ranexa in people with Cardiomyopathy and Chest Pain, run by Midwest Cardiovascular Research Foundation 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 3 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 9 Dec 2024. 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 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 6 Sep 2018). 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?

Anginal Frequency (time frame: 12 weeks). 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?

On the ClinicalTrials.gov record for NCT01345188.

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 9 Dec 2024.