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Nebivolol Versus Carvedilol in Patients With Heart Failure

NCT ID: NCT00511888

Last Updated: 2008-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-01-31

Study Completion Date

2007-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Heart Failure Hypertension

Keywords

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chronic heart failure hypertension beta blockers

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

53 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Principal Investigators

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giuseppe rosano, md

Role: STUDY_DIRECTOR

IRCCS san Raffaele Cardiovascular Research Unit

Locations

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IRCCS San Raffaele

Rome, rome, Italy

Site Status

Countries

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Italy

Other Identifiers

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001-07

Identifier Type: -

Identifier Source: org_study_id