Nebivolol Versus Carvedilol in Patients With Heart Failure

San Donato Group (GSD)

Status: Terminated

Conditions: Hypertension; Chronic Heart Failure

Study type: Observational

Funder types: Other

Identifiers

NCT00511888

001-07

Details and patient eligibility

About

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.

Enrollment: 160 patients

Sex: All

Ages: 53 to 76 years old

Volunteers: No Healthy Volunteers

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.