Nebivolol Versus Carvedilol in Patients With Heart Failure
Information source: IRCCS San Raffaele
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Heart Failure; Hypertension
Phase: N/A
Status: Terminated
Sponsored by: IRCCS San Raffaele Official(s) and/or principal investigator(s):
giuseppe rosano, md, Study Director, Affiliation: IRCCS san Raffaele Cardiovascular Research Unit
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.
RESULTS: Compared with baseline values LV end-systolic diameter decreased and LVEF increased
by a similar extent in both carvedilol (from 69+/- 27 mm to 61 +/- 27 mm and from 37% +/- 6%
to 42% +/- 9%, p< 0. 05) and nebivolol group (from 72 +/- 35 mm to 66 +/- 32mm and from 34%
+/- 7% to 38% +/- 10%, p< 0. 05) HR decreased in both groups (from 83 +/- 20 bpm to 66 +/- 11
bpm for carvedilol and from 81 +/- 15 bpm to 65 +/- 11 bpm for nebivolol; p < 0. 001 vs
baseline for both groups). A reduction in mean NYHA functional class from baseline was
observed in both groups (from 2. 5 +/- 0. 5 to 2. 2 +/- 0. 5, p < 0. 05for carvedilol and from 2. 3
+/- 0. 4 to 2. 2 +/- 0. 5, p < 0. 05 for nebivolol. The 6-minute walking showed a significant
increase in the walking distance in both groups. During 24 months 4 patients in the nebivolol
and 3 in the carvedilol group died. The overall rate of cardiac events was 22% and 26% in the
nebivolol and carvedilol group respectively.
CONCLUSION: Nebivolol is as effective as carvedilol in patients with symptomatic chronic
heart failure and reduced LV systolic function.
Clinical Details
Official title: Effects of Nebivolol Versus Carvedilol in Hypertensive Patients With Chronic Heart Failure
Study design: Natural History, Longitudinal, Random Sample, Prospective Study
Eligibility
Minimum age: 53 Years.
Maximum age: 76 Years.
Gender(s): Both.
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.
Locations and Contacts
IRCCS San Raffaele, rome 00163, Italy
Additional Information
Starting date: January 2004
Ending date: June 2007
Last updated: August 3, 2007
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