Heart Failure and a Controlled Trial Investigating Outcomes of Exercise Training

Principal Investigator: Udho Thadani, MD

Abstract:

Heart Failure and A Controlled Trial Investigating Outcomes of exercise training (HF-ACTION) is a multicenter, international, randomized trial that addresses the primary hypothesis that patients with left ventricular (LV) systolic dysfunction and New York Heart Association (NYHA) class II_IV symptoms who are given exercise training in addition to standard care will have a greater than or equal to 20% lower rate of death and hospitalization over two years than patients who receive usual care alone.  Important secondary endpoints include exercise testing parameters, economics, quality of life, and depression.

Over three years, regional centers in the US and Canada and their satellite centers will recruit 3,000 consenting patients with heart failure (HF), LC ejection fraction (EF) less than or equal to 35%, and NYHA class II-IV.  Once identified and screened, these patients will be randomized in a 1:1 fashion to receive usual care or usual care plus exercise training.  Patients in the intervention arm will undergo 36 supervised exercise training sessions before initiating a home exercise training regimen that will be supplemented with occasional supervised review training sessions.  All patients will perform gas exchange exercise tests at baseline, 3 months, 12 months, and 24 months of follow up.  All randomized patients will receive follow up clinic and telephone calls a pre-specified times.  Registries of clinical information will be maintained on eligible patients who decline trial entry.

The results of the HP-ACTION trial will have a significant impact on the health and quality of life of millions of patients who now suffer from HF.

Participant Inclusion Criteria:

1. Heart Failure

2. LC ejection fraction less than or equal to 35%

3. NYHA class II-IV

Participation Compensation:

Contact Information:

Udho Thadani, MD (405) 271-4742