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Nebivolol Versus Carvedilol in Patients With Heart Failure

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ClinicalTrials.gov Identifier: NCT00511888
Recruitment Status : Terminated (is finish)
First Posted : August 6, 2007
Last Update Posted : October 17, 2008
Sponsor:
Information provided by:
IRCCS San Raffaele

Brief Summary:

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 or disease
Chronic Heart Failure Hypertension

Study Type : Observational
Actual Enrollment : 160 participants
Time Perspective: Prospective
Official Title: Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure
Study Start Date : January 2004
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure





Information from the National Library of Medicine

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Ages Eligible for Study:   53 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00511888     History of Changes
Other Study ID Numbers: 001-07
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: October 17, 2008
Last Verified: August 2007

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

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