Japanese Chronic Heart Failure - J-CHF — Presented at AHA 2009

Nov 17, 2009
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Trial Sponsor:
Japanese Heart Foundation
Date Presented:
01/01/2009
Date Updated:
11/17/2009
Original Posted Date:
11/17/2009
References

Description:

The goal of this trial was to compare three doses of carvedilol among patients with chronic stable heart failure.

Hypothesis:

Low-dose carvedilol would be effective in preventing adverse events.

Study Design

Study Design:

Patients Enrolled: 360
Mean Follow Up: 3 years
Mean Patient Age: 59 years
Female: 26
Mean Ejection Fraction: 30%

Patient Populations:

  • Patients 20-80 years of age
  • Stable chronic heart failure with New York Heart Association class II or III
  • LVEF 40% or less

Exclusions:

  • Cardiogenic shock
  • Systolic blood pressure <80 mm Hg
  • Severe tachy- or bradyarrhythmia
  • Heart block
  • Recent myocardial infarction
  • History of coronary artery bypass grafting or percutaneous coronary intervention

Primary Endpoints:

  • All-cause death or hospitalization for cardiovascular disease or heart failure

Secondary Endpoints:

  • All-cause death
  • Hospitalization for cardiovascular disease
  • Hospitalization for heart failure
  • Death from heart failure
  • Sudden death
  • Change in LVEF
  • Change in plasma BNP

Drug/Procedures Used:

Patients with chronic stable heart failure were randomized to carvedilol 2.5 mg daily (n = 119), 5 mg daily (n = 121), or 20 mg daily (n = 120).

Principal Findings:

Overall, 360 patients were randomized. In the 2.5 mg daily group, the mean age was 59 years, 26% were women, ischemia was the cause of heart failure in 24%, mean left ventricular ejection fraction (LVEF) was 30%, and mean B-type natriuretic peptide (BNP) was 337 pg/ml.

The proportion of patients that required a change in treatment dose was 0.7% for the 2.5 mg group, 4.2% for the 5 mg group, and 23% for the 20 mg group (p < 0.05) and proportion of patients that required study drug discontinuation was 1.7%, 2.6%, and 3.4% (p = NS), respectively.

The primary outcome, death or hospitalization, occurred in 22.9% of the 2.5 mg group, 19.0% of the 5 mg group, and 21.2% of the 20 mg group (p = 0.61 for 2.5 mg vs. 5 mg and p = 0.99 for 2.5 mg vs. 20 mg). The number of all-cause deaths (n) was 9, 7, and 8; hospitalization for cardiovascular diseases was 8, 10, and 5; and hospitalization for heart failure was 21, 14, and 18 (p = NS for outcomes). LVEF increased from 30% to 43% in groups (p < 0.05 for intragroup comparisons).

Interpretation:

Among patients with chronic stable heart failure, there was no apparent difference in clinical outcomes at a mean of 3 years of follow-up among the three tested doses of carvedilol. More patients required a change in dose in the 20 mg group; however, the rate of study drug discontinuation was the same. LVEF increased to a similar degree in all three groups.

The optimal dose of a beta-blocker in patients with chronic stable heart failure remains an important question. Unfortunately, this study was significantly underpowered to detect a difference in important clinical outcomes.

References:

Presented by Dr. Mosatsugu Hori at the American Heart Association Scientific Sessions, Orlando, FL, November 17, 2009.

Keywords: Follow-Up Studies, Adrenergic alpha-1 Receptor Antagonists, Carbazoles, Heart Failure, Stroke Volume, Propanolamines, Vasodilator Agents, Natriuretic Peptide, Brain


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