Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure (CARNEBI)
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
carvedilol
bisoprolol
Nebivolol
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Heart Failure focused on measuring exercise, lung diffusion, hypoxia, chemoreceptor, beta-blockers, heart failure
Eligibility Criteria
Inclusion Criteria:
- Chronic heart failure patients in stable clinical condition
Exclusion Criteria:
- No comorbidity
- NYHA class IV
Sites / Locations
- Centro Cardiologico Monzino, University of Milan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Carvedilol
Bisoprolol
Nebivolol
Arm Description
Outcomes
Primary Outcome Measures
exercise capacity
Secondary Outcome Measures
lung diffusion
Full Information
NCT ID
NCT00517725
First Posted
August 16, 2007
Last Updated
September 15, 2010
Sponsor
Centro Cardiologico Monzino
1. Study Identification
Unique Protocol Identification Number
NCT00517725
Brief Title
Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure
Acronym
CARNEBI
Official Title
Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure: Effects on Exercise Capacity and Hypoxia, Chemoreceptor Response, Pulmonary Function
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centro Cardiologico Monzino
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators test the hypothesis that different beta-blockers had a different influence on chemoreceptor response and lung diffusion capacity.
Both could influence exercise capacity in normoxic as well as hypoxic conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
exercise, lung diffusion, hypoxia, chemoreceptor, beta-blockers, heart failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carvedilol
Arm Type
Active Comparator
Arm Title
Bisoprolol
Arm Type
Active Comparator
Arm Title
Nebivolol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
carvedilol
Intervention Type
Drug
Intervention Name(s)
bisoprolol
Intervention Type
Drug
Intervention Name(s)
Nebivolol
Primary Outcome Measure Information:
Title
exercise capacity
Time Frame
two months
Secondary Outcome Measure Information:
Title
lung diffusion
Time Frame
two months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chronic heart failure patients in stable clinical condition
Exclusion Criteria:
No comorbidity
NYHA class IV
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piergiuseppe Agostoni, MD, PhD
Organizational Affiliation
Centro Cardiologico Monzino
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Giancarlo Marenzi, MD
Organizational Affiliation
Centro Cardiologico Monzino
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Cardiologico Monzino, University of Milan
City
Milan
ZIP/Postal Code
20138
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
17028107
Citation
Agostoni P, Bussotti M, Cattadori G, Margutti E, Contini M, Muratori M, Marenzi G, Fiorentini C. Gas diffusion and alveolar-capillary unit in chronic heart failure. Eur Heart J. 2006 Nov;27(21):2538-43. doi: 10.1093/eurheartj/ehl302. Epub 2006 Oct 6.
Results Reference
background
PubMed Identifier
21450573
Citation
Karsten M, Contini M, Cefalu C, Cattadori G, Palermo P, Apostolo A, Bussotti M, Magri D, Salvioni E, Farina S, Sciomer S, Catai AM, Agostoni P. Effects of carvedilol on oxygen uptake and heart rate kinetics in patients with chronic heart failure at simulated altitude. Eur J Prev Cardiol. 2012 Jun;19(3):444-51. doi: 10.1177/1741826711402736. Epub 2011 Mar 7.
Results Reference
derived
Learn more about this trial
Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure
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