Initiation Management Predischarge: Process for Assessment of Carvedilol Therapy in Heart Failure - IMPACT-HF
The goal of the Initiation Management Predischarge: Process for Assessment of Carvedilol Therapy in Heart Failure (IMPACT-HF) trial was to evaluate treatment with carvedilol initiation predischarge compared with postdischarge initiation (>2 weeks) in stabilized patients hospitalized for heart failure.
Predischarge initiation of the beta-blocker carvedilol may improve the use of beta-blockade therapy at two months.
Patients Screened: 1,887
Patients Enrolled: 363
Mean Follow Up: 60 days
Mean Patient Age: Median age 67 years
Mean Ejection Fraction: Median LVEF at randomization 25%
LVEF <40% and hospitalized with a primary diagnosis of heart failure
Treatment with a beta-blocker within 30 days of randomization; decompensated New York Heart Association functional class IV heart failure requiring inotropic support at randomization; second- or third-degree atrioventricular block, sick sinus syndrome, or symptomatic bradycardia without a functional pacemaker; bronchial asthma or related bronchospastic conditions; symptomatic hypotension defined by the investigator; cardiogenic shock; expected survival <60 days; hypersensitivity to carvedilol; clinically manifest hepatic impairment; or being pregnant or lactating
Number of patients treated with beta-blockade at 60 days after randomization
Number of patients discontinuing beta-blockade, median dose achieved, and a composite of death, rehospitalization, unscheduled visit for heart failure, or ≥50% increase in oral diuretic, new oral diuretic, or any intravenous therapy with diuretics, inotropes, or other vasoactive agents
Patients with stable heart failure were randomized to carvedilol initiation prehospital discharge (n=185) or to postdischarge initiation (>2 weeks) of beta-blockade at the discretion of the physician (n=178).
Angiotensin-converting enzyme inhibitors: 74%
Baseline characteristics were similar between groups, with a median left ventricular ejection fraction (LVEF) of 25% in each group and median time from admission to randomization of 60.9 hours. Median time to initiation of beta-blocker therapy was 17 days in the postdischarge beta-blocker initiation group.
The primary endpoint of beta-blocker use at 60 days was significantly higher in the predischarge carvedilol initiation group compared with the postdischarge initiation group (91.2% vs. 73.4%, p<0.0001). Target beta-blocker dose was achieved more frequently in the predischarge initiation group (36.3% vs. 28.6%). The frequency of permanent beta-blocker discontinuation was similar between the two groups (10.5% in the predischarge initiation group vs. 10.6% in the postdischarge group).
There was no difference in the composite endpoint between groups (45.4% in the predischarge initiation group vs. 46.1% in the postdischarge group, p=0.9) or any of the individual components of the composite. There was no increase in serious adverse events in the predischarge initiation group, with hypotension reported in 1.6% of the predischarge group versus 0.6% of the postdischarge group and bradycardia in 1.6% and 0%, respectively. The median length of hospitalization was five days in both groups.
Among stabilized patients hospitalized for heart failure, initiation of beta-blocker therapy with carvedilol predischarge was associated with increased beta-blocker use at 60-day follow-up compared with initiation of beta-blocker therapy after discharge at the discretion of the physician.
The Heart Failure Society of America heart failure guidelines recommend beta-blocker use in patients with chronic heart failure and reduced systolic function, but that beta-blockers should not be routinely initiated during a hospitalization for worsening heart failure. Data from the Acute Decompensated Heart Failure (ADHERE) registry show that beta-blocker use in these patients is widely underutilized, with only 58% of eligible patients receiving the therapy at hospital discharge.
The recommendation to not initiate beta-blocker use during hospitalization for worsening heart failure is based on concern that beta-blocker therapy may worsen heart failure symptoms and short-term outcomes. However, the present data do not show an increase in adverse events in the predischarge initiation group. Additionally, a subgroup analysis of the COPERNICUS study showed no increase in worsening heart failure symptoms or adverse events.
A limitation of the present study is the open-label trial design, which may have contributed to the high treatment adherence at 60 days in both groups.
Gattis WA, O'Connor CM, Gallup DS, Hasselblad V, Gheorghiade M, on behalf of the IMPACT-HF Investigators and Coordinators. Predischarge initiation of carvedilol in patients hospitalized for decompensated heart failure: results of the Initiation Management Predischarge: Process for Assessment of Carvedilol Therapy in Heart Failure (IMPACT-HF) trial. J Am Coll Cardiol 2004;43:1534-41.
Keywords: Registries, Follow-Up Studies, Carbazoles, Heart Failure, Hypotension, Stroke Volume, Bradycardia, Propanolamines
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