Controlled study of myocardial recovery after interval training in XXXX : SMARTEX-HF--rationale and design.

@entity1 @entity712 @entity26 @entity2101 @entity204
BACKGROUND: The large randomized controlled multicentre clinical trial, HF-ACTION, recently demonstrated that a programme of recommendation of regular exercise training at moderate intensity is safe, improves quality of life, and reduces the combined endpoint of all-cause @entity204 and hospitalization in @entity1 with @entity712 . However, the size of beneficial effects was modest compared to results published in smaller single studies and meta-analyses. OBJECTIVE: Based on results of a pilot study, the objective of the present investigation is to test the hypothesis that a programme comprising interval training at high relative intensity would yield significantly larger effects in terms of left ventricular remodelling compared to moderate continuous exercise training. STUDY DESIGN: In a three-armed randomized multicentre study of stable @entity712 @entity1 with left ventricular ejection fraction  <=35%, the effects of a 12-week programme of @entity2101 ( @entity2101 ; 85-90% of peak @entity26 uptake, VO(2peak)) will be compared to actual practice in Europe, represented by either an isocaloric programme of moderate continuous training (MCT; 50-60% of VO(2peak)) and a recommendation of regular exercise (RE) of the individual @entity1 ' own preference based on clinical practice at the local centre. The primary endpoint is reverse remodelling, defined as change in left ventricular end-diastolic diameter assessed by echocardiography. Secondary endpoints include peak @entity26 uptake (VO(2peak)), biomarkers, quality of life, and level of physical activity assessed by questionnaires. In addition, long-term maintenance of effects after the supervised training period will be determined. Assessments will be made at baseline, after the 12-week intervention programme, and at 1-year follow up. A total number of 200 @entity1 on treatment per protocol, randomized to the three groups in a 1   :   1   :   1 manner, is estimated to detect clinically relevant differences in effect with @entity2101 vs. MCT and RE (p   <   0.05; statistical power 0.90) for the primary endpoint. Inclusion of @entity1 started May 2009 and will run until total number has been reached.
