Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
121 participants
INTERVENTIONAL
2009-09-30
2010-10-31
Brief Summary
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Detailed Description
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Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and Ivabradine up to 12.5/5 mg b.i.d.
Efficacy measure Intention to treat Exercise tolerance Quality of life
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ivabradine
7.5 mg bd
ivabradine
7.5 mg bd
Carvedilol
up to 25 mg bd
Carvedilol
25 mg bd
"Drug:Carvedilol" and "Drug:Ivabradine"
up to 12.5/5 mg bd
"Drug:Carvedilol" and "Drug:Ivabradine"
up to 12.5/5 mg bd
Interventions
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ivabradine
7.5 mg bd
"Drug:Carvedilol" and "Drug:Ivabradine"
up to 12.5/5 mg bd
Carvedilol
25 mg bd
Eligibility Criteria
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Inclusion Criteria
* ischemic origin
* stable medications from at least 3 months
* \> 3 months from an acute ischemic syndrome or revascularization procedure
* naive on heart rate reducing agents
Exclusion Criteria
* hypersensitivity or contraindications to study drugs
* exercise tolerance at 6 minute walking test \<100 m or \>400 m
35 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Giuseppe M.C. Rosano
Principal investigato
Principal Investigators
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Maurizio Volterrani, MD
Role: PRINCIPAL_INVESTIGATOR
IRCCS San Raffaele
Giuseppe MC Rosano, MD, PhD
Role: STUDY_CHAIR
IRCCS San Raffaele
Cristiana Vitale, MD, PhD
Role: STUDY_DIRECTOR
IRCCS San Raffaele
Locations
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Centre for Clinical and Basic Research - IRCCS San Raffaele
Roma, Italy, Italy
IRCCS San Raffaele
Roma, Italy, Italy
Countries
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References
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Fasullo S, Cannizzaro S, Maringhini G, Ganci F, Giambanco F, Vitale G, Pinto V, Migliore G, Torres D, Sarullo FM, Paterna S, Di Pasquale P. Comparison of ivabradine versus metoprolol in early phases of reperfused anterior myocardial infarction with impaired left ventricular function: preliminary findings. J Card Fail. 2009 Dec;15(10):856-63. doi: 10.1016/j.cardfail.2009.05.013. Epub 2009 Jul 3.
Swedberg K, Komajda M, Bohm M, Borer JS, Ford I, Tavazzi L. Rationale and design of a randomized, double-blind, placebo-controlled outcome trial of ivabradine in chronic heart failure: the Systolic Heart Failure Treatment with the I(f) Inhibitor Ivabradine Trial (SHIFT). Eur J Heart Fail. 2010 Jan;12(1):75-81. doi: 10.1093/eurjhf/hfp154. Epub 2009 Nov 5.
Related Links
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European Society Cardiology guidelines
Other Identifiers
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CTG001-07
Identifier Type: -
Identifier Source: org_study_id
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