NCT00917046

The SMARTEX Heart Failure Study

Study of Myocardial Recovery After Exercise Training in Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 261 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol describes a randomized multicenter clinical trial designed to test the hypothesis that a 12-week program of high-intensity interval training (HIIT) yields larger beneficial effects in stable heart failure patients than current practice, defined as either a similar training program with the same volume of moderate continuous training (MCT) or a recommendation of regular exercise at moderate intensity at individual choice (RRE).

Detailed description

Evaluation criteria are left ventricular dimensions and function measured by echocardiography, aerobic capacity measured as peak oxygen uptake, quality of life, and the level of physical activity by questionnaires. Assessments will be made before and after the training program and at one year follow-up. Safety of HIIT will be assessed as incidence of adverse effects during the training program. Clinical events will be recorded as worsening of heart failure requiring intensified drug therapy (diuretics), ventricular arrhythmia, hospitalization due to cardiovascular disease, and all-cause mortality at one year follow-up. The core study has been initiated and endorsed by the European Association for Cardiovascular Prevention and Rehabilitation, Section for Basic and Translational Research, under the European Society of Cardiology, and allows for sub-studies involving one or more of the participating centers. Preliminary calculations suggest that a total number of 200 patients randomized 1:1:1 to the three intervention groups is needed to detect larger beneficial effects with HIIT with a p-value of 0.05 and statistical power of 0.90 (primary endpoint is reverse remodeling, assessed by comparison between groups of change in left ventricular end-diastolic dimension from baseline to 12 weeks).

Conditions

• Heart Failure

Interventions

Type	Name	Description
BEHAVIORAL	high-intensity interval training	3 weekly sessions of high-intensity interval training in 12 weeks
BEHAVIORAL	Moderate continuous training	3 weekly sessions of moderate continuous training for 12 weeks
BEHAVIORAL	Recommendation of regular moderate exercise	Recommendation of regular exercise at moderate intensity at individual choice. In addition patients will meet for treadmill walking in order to motivate for post intervention testing

Timeline

• Start date: 2009-01-01
• Primary completion: 2013-09-01
• Completion: 2014-07-01
• First posted: 2009-06-10
• Last updated: 2019-11-14

Locations

11 sites across 7 countries: Belgium, Denmark, Germany, Italy, Luxembourg, Netherlands, Norway