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1984

Circulation

November 9, 2010

Table 2.

Summary of Previous AHFS Clinical Trials From the Past Decade

Study Acronym VMAC240

OPTIME-CHF241

Year of Publication

2002

2002

Primary End Point

Coprimary

  • 1.

    Change in PCWP at 3 h

  • 2.

    Change in dyspnea (Likert) at 3 h

Cumulative days of hospital stay for cardiovascular cause or days dead within 60 d after random selection

Key Secondary End Points

PCWP at 24 h, dyspnea at 24 and 48 h, global clinical status

Proportion of cases in which therapy failed because of adverse events or worsening heart failure (sustained SBP 80 mm Hg, myocardial ischemia, arrhythmias, persistent CHF, inadequate diuresis, organ hypoperfusion), HF score, global health (VAS)

ESCAPE118

2005

Days alive and out of hospital during the first 6 mo

Adverse events related to catheter use, 6-min walk duration, QOL via time trade-off, and MLHF

VERITAS242

SURVIVE243

2007

2007

Coprimary

  • 1.

    Change in dyspnea (at 3, 6, and 24 h with VAS 0–100) over 24 h (area under the curve)

  • 2.

    Death or worsening heart failure (pulmonary edema, shock, new or 1 intravenous therapy, mechanical cardiac or pulmonary support, renal replacement therapy) at 7 d

All-cause mortality at 180 d

Death or major cardiovascular events at 30 d; improved hemodynamic measures over 24 h; LOS; days hospitalized within 30 d; 6-mo mortality

All-cause mortality at 31 d; days alive or out of hospital at 180 d; cardiovascular mortality at 180 d; change in BNP level at 24 h; dyspnea at 24 h; patient-assessed global assessment at 24 h

REVIVE-II244

Not yet published (presented 2005)

Composite of clinical signs and symptoms of HF over 5 d expressed as 3-stage end point:

Change in BNP; mortality at 90 d

1. Better (moderately or markedly improved global assessment at 6 h, 24 h, and 5 d with no worsening)

2. Same

EVEREST80,245

ASCEND-HF246

PROTECT I and II247

2007

Enrolling

Completed, presented 2009 not yet published

3. Worse (death from any cause, persistent or worsening HF requiring intravenous diuretic agents, vasodilators, or inotropes at any time; or moderately or markedly worse patient global assessment at 6 h, 24 h, or 5 d)

Short-term composite: changes in global clinical status (by VAS) and body weight at day 7 or discharge. Long-term dual end points:

  • 1.

    All-cause mortality (superiority and noninferiority)

  • 2.

    Cardiovascular death or HF hospital stay (superiority only)

Coprimary

1. Composite of all-cause mortality and HF repeat hospital stay through 30 d

2. Dyspnea at 6 and 24 h

Composite of clinical signs and symptoms of HF over 7 d expressed as 3-stage end point:

1. Better (moderately or markedly improved global assessment at 24 and 48 h with no worsening)

2. Same

Composite components in isolation at days 1 and 7 or discharge; dyspnea at day 1; peripheral edema at day 7 or discharge; KCCQ at 1 wk and 6 mo; body weight; changes in serum sodium

Overall well-being (Likert) 6 and 24 h; days alive and outside of hospital within 30 d

Safety; within trial costs

3. Worse (death from any cause, persistent or worsening heart failure through day 7, or creatinine increase 0.3 mg/dL at 7 and 14 d)

PCWP indicates pulmonary capillary wedge pressure; SBP, systolic blood pressure; CHF, congestive heart failure; QOL, quality of life; MLHF, Minnesota Living with Heart Failure Questionnaire; VAS, Visual Analog Scale; LOS, length of stay; BNP, b-type natriuretic peptide; and KCCQ, Kansas City Cardiomyopathy Questionnaire. Adapted from Allen et al,198 with permission from Elsevier. Copyright 2009, American College of Cardiology.

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