Nebivolol Versus Carvedilol in Patients With Heart Failure

Hypertension Clinical Trial

Official title:

Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00511888
• Other study ID #: 001-07
• Status: Terminated
• Phase: N/A
• First received: August 3, 2007
• Last updated: October 16, 2008
• Start date: January 2004
• Est. completion date: June 2007

Study information

• Verified date: August 2007
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 53 Years to 76 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure
• Hypertension

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Rome

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy,