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NCT Number: NCT01345188

Ranolazine in Ischemic Cardiomyopathy

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.

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Key information

Conditions

Cardiomyopathy Cardiomyopathies Cardiovascular Diseases Chest Pain Dyspnea Heart Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

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

Treatment and study plan

Ranexa

Drug

1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Other names: Ranolazine

Placebo

Drug

1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Midwest Cardiovascular Research Foundation

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2011
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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