Primary Outcome Measures:
- Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3) [ Time Frame: measured as events occur during the lifespan of the trial. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes in peak VO2 [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
- Changes in VE/VCO2 slope [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
- Heart rate at a submaximal work load defined as the end of the exercise test's second stage [ Time Frame: Measured at 3 months, 12 months, and 24 months. ] [ Designated as safety issue: No ]
- Changes in 6-minute walk (measured at Month 3 and Year 1) [ Time Frame: Measured at 3 months, 12 months, 24 months, 36 months, and at end of study. ] [ Designated as safety issue: No ]
- Composite of cardiovascular mortality and cardiovascular hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Composite of cardiovascular mortality and CHF hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- All-cause mortality rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Cardiovascular mortality rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- All-cause hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- CHF hospitalization rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Heart attack rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Worsening CHF event rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Composite of all-cause mortality, all-cause hospitalization, emergency room visit, and urgent clinic visit for CHF exacerbation rates [ Time Frame: Measured as events occur during the life of the trial. ] [ Designated as safety issue: Yes ]
- Cost [ Time Frame: Measured throughout the life of the trial. ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: Measured at baseline, months 3, 6, 9, 12, 15, 18, 21, 24, 36, and end of study ] [ Designated as safety issue: No ]
BACKGROUND:
CHF affects approximately five million Americans and is the number one cause of hospital admission in individuals over the age of 65. Although exercise training improves several clinical measures in individuals with CHF (e.g., peak VO2, heart rate variability, and plasma norepinephrine levels), it is not known whether exercise training reduces mortality in individuals with CHF.
DESIGN NARRATIVE:
This multicenter randomized study will determine if exercise training reduces mortality and hospitalization rates in individuals with moderate to severe CHF. The secondary objective is to evaluate whether an exercise program designed for individuals with CHF improves quality of life and functioning, is economically advantageous, and prevents medical complications.
Three thousand individuals with moderate to severe CHF will be randomly assigned to either standard medical therapy and education, or standard medical therapy and education plus a supervised exercise training program. The exercise training will include 36 supervised clinic-based training sessions followed by home-based exercise and periodic supervised sessions for reinforcement. Participants assigned to the supervised exercise training program will use either a treadmill or stationary bicycle, which will be provided for them.
Recruitment Status: As of November 9, 2006, HF-ACTION has enrolled 2180 subjects and will conclude enrollment at the end of February, 2007, with an anticipated enrollment of approximately 2300 subjects.