Ranolazine in Ischemic Cardiomyopathy

• Sponsor: Midwest Cardiovascular Research Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT01345188
• Collaborator: Gilead Sciences (Industry)
• Enrollment: 28
• Location: 1
• Arms: 2
• Duration (Months): 36
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief 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) cardiomyopathy treated with optimal conventional medical therapy and/or percutaneous revascularization.

Condition or Disease	Intervention/Treatment	Phase
Cardiomyopathy; Chest Pain; Dyspnea	Drug: Ranexa; Drug: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 28 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Apr 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ranolazine 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug: Ranexa; 1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.; Other Names: Ranolazine
Placebo Comparator: Placebo 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.	Drug: Placebo; 1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Outcome Measures

Primary Outcome Measures

1. Anginal Frequency [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.

2. Quality of Life [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.

3. Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ) [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 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.

2. Anginal chest pain or dyspnea

3. Documentation of non treatable or optimally treated coronary artery disease

4. Ejection Fraction of less than or equal to 40%

Exclusion Criteria:

1. Less than 18 years of age

2. Pregnant or breast feeding

3. Patients with non ischemic cardiomyopathy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Midwest Cardiovascular Research Foundation	Davenport	Iowa	United States	52803

Sponsors and Collaborators

• Midwest Cardiovascular Research Foundation
• Gilead Sciences

Investigators

• Principal Investigator: Nicolas W Shammas, MD, Midwest Cardiovascular Research Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Nicolas Shammas, Principal Investigator, MD, Midwest Cardiovascular Research Foundation
• ClinicalTrials.gov Identifier: NCT01345188
• Other Study ID Numbers: IN-US-259-D032
• First Posted: Apr 29, 2011
• Last Update Posted: Mar 4, 2020
• Last Verified: Feb 1, 2020

• Additional relevant MeSH terms: Dyspnea; Cardiomyopathies; Chest Pain; Ranolazine

Study Results

Participant Flow

Recruitment Details	Participants recruited from a cardiovascular clinic in Davenport, Iowa between 5/21/2012 and 11/22/2013
Pre-assignment Detail	A total of 36 patients assessed for eligibility. Excluded were 8 patients (did not meet inclusion criteria=4; declined to participate=3;other=1). 28 patients were included in this randomized cross-over study.

Arm/Group Title	Ranolazine, Then Placebo
Arm/Group Description	Patient received Ranolazine to 1,000 mg ranolazine orally twice a day, as tolerated for 6 weeks. After a washout period of 2 weeks, they then received Placebo tablet (matching Ranolazine 1000 mg tablet twice a week) for 6 weeks.
Period Title: Randomization Ranolazine/Placebo 6 Weeks
STARTED	28
COMPLETED	26
NOT COMPLETED	2
Period Title: Randomization Ranolazine/Placebo 6 Weeks
STARTED	26
COMPLETED	25
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	Includes both groups randomized to placebo and ranolazine
Overall Participants	28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.5 (8.4)
Sex: Female, Male (Count of Participants)
Female	5 17.9%
Male	23 82.1%
Ejection Fraction (Percentage) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Percentage]	33.1 (7.6)
Diabetes Mellitus (participants) [Number]
Number [participants]	19 67.9%
Prior myocardial infarction (participants) [Number]
Number [participants]	23 82.1%

Outcome Measures

1. Primary Outcome

Title	Anginal Frequency
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ranolazine	Placebo
Arm/Group Description	Patients that received placebo
Measure Participants	24	24
Mean (Full Range) [units on a scale]	86.67	74.44

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ranolazine, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.058
	Comments
	Method	Paired t test
	Comments

2. Primary Outcome

Title	Quality of Life
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Ranolazine	Placebo
Arm/Group Description	Patients that received ranolazine	Patients that received placebo
Measure Participants	24	24
Mean (Full Range) [units on a scale]	72.22	66.67

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ranolazine, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	Paired t test
	Comments

3. Primary Outcome

Title	Dyspnea Assessed by the Rose Dyspnea Questionnaire (RDQ)
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Ranolazine	Placebo
Arm/Group Description	Patients that received ranolazine	Patients that received placebo
Measure Participants	20	20
Mean (Full Range) [units on a scale]	-0.45	-0.34

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ranolazine, Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments
	Method	Wilcoxon Signed rank
	Comments

Adverse Events

Time Frame	12 weeks
Arm/Group Title	Ranolazine		Placebo
Arm/Group Description	patients receiving ranolazine		Patients receiving placebo
All Cause Mortality
	Ranolazine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/24 (0%)
Serious Adverse Events
	Ranolazine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/24 (8.3%)		0/24 (0%)
Cardiac disorders
Heart failure	1/24 (4.2%)	1	0/24 (0%)	0
Nervous system disorders
stroke	1/24 (4.2%)	1	0/24 (0%)	0
Other (Not Including Serious) Adverse Events
	Ranolazine		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/24 (25%)		2/24 (8.3%)
Gastrointestinal disorders
Nausea	2/24 (8.3%)	2	0/24 (0%)	0
constipation	2/24 (8.3%)	2	0/24 (0%)	0
Nervous system disorders
diziness	3/24 (12.5%)	3	2/24 (8.3%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.