NCT01721967

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
9 months until next milestone

Results Posted

Study results publicly available

January 18, 2017

Completed
Last Updated

March 3, 2017

Status Verified

January 1, 2017

Enrollment Period

3 years

First QC Date

November 2, 2012

Results QC Date

November 4, 2016

Last Update Submit

January 19, 2017

Conditions

Hypertrophic Cardiomyopathy

Keywords

chest paindyspnea

Outcome Measures

Primary Outcomes (3)

  • QT Interval

    60 Days

  • Number of Adverse Events Considered Probably or Possibly Related to Study Drug

    Number of events that are considered probably or possibly related to study drug.

    60 Days

  • Drug Tolerability

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

    60 days

Secondary Outcomes (3)

  • Improvement in Number of Episodes of Angina Per Week

    Baseline and 60 Days post treatment

  • Seattle Angina Questionnaire (SAQ)

    60 Days post treatment

  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

    60 days post treatement

Study Arms (1)

Ranolazine

EXPERIMENTAL

Ranolazine, 500 mg for 60 days

Drug: Ranolazine

Interventions

RanolazineDRUG
Also known as: Ranexa
Ranolazine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Cardiomyopathy, HypertrophicChest PainDyspnea

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

CardiomyopathiesHeart DiseasesCardiovascular DiseasesAortic Stenosis, SubvalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Andrew Wang, MD
Organization
Duke University Health System
a.wang@duke.edu
919-681-6197

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2012

First Posted

November 6, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

May 1, 2016

Last Updated

March 3, 2017

Results First Posted

January 18, 2017

Record last verified: 2017-01

Locations

US(1)