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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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10 May 2021 |
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Main ID: |
NCT02133911 |
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Date of registration:
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06/05/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Pilot Trial of Ranolazine to Treat Patients With Dilated Cardiomyopathy
RAMP-DCM |
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Scientific title:
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Effects of Ranolazine on Myocardial Perfusion in Patients With Dilated Cardiomyopathy |
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Date of first enrolment:
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May 1, 2014 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02133911 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Slovenia
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Contacts
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Name:
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Bojan Vrtovec, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia |
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Name:
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Gregor Poglajen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Advanced Heart Failure and Transplantation Programme, University Medical Center Ljubljana, Slovenia |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- established diagnosis of non-ischemic dilated cardiomyopathy
- EF < 35%
- NYHA f.c. II - IV
- Optimal medical management > 6 months
- Age < 75 years and > 18 years
Exclusion Criteria:
- known hypersensitivity to the medication
- age > 75 years or < 18 years
- EF > 35%
- renal insufficiency (GF < 30)
- liver dysfunction (liver tests > 3x the upper normal limit))
- LQT syndrome
- drugs that affect CYP3A4 metabolism (azoles, macrolides, calcineurin inhibitors etc.)
- dementia
- active hemathological or malignant disease
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dilated Cardiomyopathy
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Intervention(s)
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Drug: Ranolazine
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Primary Outcome(s)
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Myocardial perfusion
[Time Frame: 6 months]
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Secondary Outcome(s)
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Supraventricular and ventricular arrhythmias
[Time Frame: 6 months]
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Excercise capacity
[Time Frame: 1, 3 and 6 months]
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Left ventricular systolic and diastolic function
[Time Frame: 1, 3 and 6 months]
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Secondary ID(s)
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AHFTX-UMCLJ-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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