Nebivolol Versus Carvedilol in Patients With Heart Failure

October 16, 2008 updated by: IRCCS San Raffaele

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00163
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 76 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

August 3, 2007

First Submitted That Met QC Criteria

August 3, 2007

First Posted (ESTIMATE)

August 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

October 17, 2008

Last Update Submitted That Met QC Criteria

October 16, 2008

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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