Nebivolol Versus Carvedilol in Patients With Heart Failure - Full Text View

Sponsor:	IRCCS San Raffaele
Information provided by:	IRCCS San Raffaele
ClinicalTrials.gov Identifier:	NCT00511888

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:	Prospective
Official Title:	Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure High Blood Pressure

Drug Information available for: Carvedilol Nebivolol

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

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

Keywords provided by IRCCS San Raffaele:

chronic heart failure
hypertension
beta blockers

Additional relevant MeSH terms:

Vasodilator Agents
Heart Failure
Neurotransmitter Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Vascular Diseases
Nebivolol
Adrenergic alpha-Antagonists

Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Hypertension
Carvedilol

ClinicalTrials.gov processed this record on February 08, 2010