Ranolazine in Ischemic Cardiomyopathy Patients With Persistent Chest Pain or Dyspnea Despite Conventional Therapy: A Cross-Over Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Anginal Frequency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%
排除标准
- •Less than 18 years of age
- •Pregnant or breast feeding
- •Patients with non ischemic cardiomyopathy
研究组 & 干预措施
Ranolazine
1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
干预措施: Ranexa (Drug)
Placebo
1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
干预措施: Placebo (Drug)
结局指标
主要结局
Anginal Frequency
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
未报告次要终点
研究者
Dr. Nicolas Shammas
Principal Investigator, MD
Midwest Cardiovascular Research Foundation