Nebivolol Versus Carvedilol in Patients With Heart Failure
- Conditions
- Chronic Heart FailureHypertension
- Registration Number
- NCT00511888
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
IRCCS San Raffaele
🇮🇹Rome, Italy