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Nebivolol Versus Carvedilol in Patients With Heart Failure

This study has been terminated.
(is finish)
Sponsor:
Information provided by:
IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT00511888
First received: August 3, 2007
Last updated: October 16, 2008
Last verified: August 2007
History of Changes
  Purpose

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.


Condition
Chronic Heart Failure
Hypertension

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by IRCCS San Raffaele:

Enrollment: 160
Study Start Date: January 2004
Study Completion Date: June 2007
  Eligibility

Ages Eligible for Study:   53 Years to 76 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511888

Locations
Italy
IRCCS San Raffaele
Rome, Italy, 00163
Sponsors and Collaborators
IRCCS San Raffaele
Investigators
Study Director: giuseppe rosano, md IRCCS san Raffaele Cardiovascular Research Unit
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00511888     History of Changes
Other Study ID Numbers: 001-07
Study First Received: August 3, 2007
Last Updated: October 16, 2008
Health Authority: Italy: Ethics Committee

Keywords provided by IRCCS San Raffaele:
chronic heart failure
hypertension
beta blockers

Additional relevant MeSH terms:
Heart Failure
Hypertension
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Carvedilol
Nebivolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic beta-1 Receptor Antagonists

ClinicalTrials.gov processed this record on June 18, 2013