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Completed

NCT Number: NCT01721967

Ranolazine for the Treatment of Chest Pain in HCM Patients

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).

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Chest Pain Dyspnea Heart Diseases Heart Valve 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

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • 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

Treatment and study plan

Ranolazine

Drug

Other names: Ranexa

Primary outcomes

  1. QT Interval

    Time frame: 60 Days

  2. 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.

  3. Drug Tolerability

    Time frame: 60 days

    Total number of patients that tolerated 1,000mg BID dose and 500 mg BID dose

Secondary outcomes

  1. Improvement in Number of Episodes of Angina Per Week

    Time frame: Baseline and 60 Days post treatment

    Efficacy of ranolazine in HCM patients with respect to improvements in angina frequency (number of episodes of angina per week).

  2. Seattle Angina Questionnaire (SAQ)

    Time frame: 60 Days post treatment

    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.

  3. Kansas City Cardiomyopathy Questionnaire (KCCQ)

    Time frame: 60 days post treatement

    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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

Ranolazine for the Treatment of Angina in Hypertrophic Cardiomyopathy Investigation

Acronym: RHYME

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Nov 6, 2012
Registry last updated
Mar 3, 2017

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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