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Nebivolol Versus Carvedilol in Patients With Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00511888
Recruitment Status : Terminated (is finish)
First Posted : August 6, 2007
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:

August 3, 2007
August 6, 2007
October 17, 2008
January 2004
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Complete list of historical versions of study NCT00511888 on ClinicalTrials.gov Archive Site
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Nebivolol Versus Carvedilol in Patients With Heart Failure
Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure

BACKGROUND Beta-blockers improve left ventricular (LV) systolic function and prognosis in patients with chronic heart failure. Both carvedilol and nebivolol have hemodynamic and clinical benefits in chronic heart failure (CHF), but it is unknown whether their pleiotropic properties may play a role in different subgroups of patients with CHF.

OBJECTIVE: To compare the effects of nebivolol and carvedilol on LV function and clinical outcome in patients with chronic heart failure and reduced LV systolic function.

METHODS: 160 hypertensive CHF patients, LV ejection fraction (EF) 40% and in New York Heart Association (NYHA) functional class II or III were randomly assigned to receive carvedilol or nebivolol therapy for 24 months. At baseline and after 24 months of treatment, all patients underwent clinical evaluation: echocardiogram and 6-minute walking test.

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Observational
Time Perspective: Prospective
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  • Chronic Heart Failure
  • Hypertension
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
June 2007
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Inclusion Criteria:

  • left ventricular ejection fraction (LVEF) < 40%;
  • symptomatic heart failure with functional New York Heart Association (NYHA) class II or III;
  • arterial hypertension with systolic blood pressure >140 mmHg and diastolic blood pressure >85 mmHg;
  • clinical stability without hospital admission for heart failure in the previous 3 months.

Exclusion Criteria:

  • history of asthma or severe chronic obstructive pulmonary disease;
  • severe liver or kidney diseases;
  • second-degree or third degree heart block without a permanent pacemaker,
  • sick sinus syndrome, heart rate <60 beat/min, systolic blood pressure <90 mmHg.
Sexes Eligible for Study: All
53 Years to 76 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT00511888
001-07
Yes
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IRCCS San Raffaele
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Study Director: giuseppe rosano, md IRCCS san Raffaele Cardiovascular Research Unit
IRCCS San Raffaele
August 2007