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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
Centro Cardiologico Monzino
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
August 16, 2007
Last Updated
September 15, 2010
Sponsor
Centro Cardiologico Monzino
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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

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Nebivolol Versus Bisoprolol Versus Carvedilol in Heart Failure

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