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The SMARTEX Heart Failure Study (SMARTEX)

This study has been completed.
Sponsor:
Collaborators:
University Hospital, Antwerp
UMC Utrecht
Technische Universität München
Heartcenter Leipzig GmbH
Bispebjerg Hospital
St. Olavs Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00917046
First received: June 8, 2009
Last updated: August 19, 2016
Last verified: August 2016
History of Changes

June 8, 2009
August 19, 2016
January 2009
June 2013   (final data collection date for primary outcome measure)
Left ventricular end diastolic diameter between baseline and 12 weeks [ Time Frame: Baseline-12 weeks ] [ Designated as safety issue: No ]
Cardiac volumes and functions (reverse remodeling and improved left ventricular function) [ Time Frame: Baseline-12 weeks- 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00917046 on ClinicalTrials.gov Archive Site
  • Exercise capacity [ Time Frame: baseline-12 weeks- 1year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline - 12 weeks - 1 year ] [ Designated as safety issue: No ]
  • level of physical activity [ Time Frame: baseline-12 weeks- 1 year ] [ Designated as safety issue: No ]
  • safety and adverse events [ Time Frame: baseline-12 weeks - 1 year ] [ Designated as safety issue: No ]
  • Change in Ejection fraction [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Exercise capacity [ Time Frame: baseline-12 weeks- 1year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline - 12 weeks - 1 year ] [ Designated as safety issue: No ]
  • level of physical activity [ Time Frame: baseline-12 weeks- 1 year ] [ Designated as safety issue: No ]
  • safety and adverse events [ Time Frame: baseline-12 weeks - 1 year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
The SMARTEX Heart Failure Study
Study of Myocardial Recovery After Exercise Training in Heart Failure
This protocol describes a randomized multicenter clinical trial designed to test the hypothesis that a 12-week program of aerobic interval training (AIT) 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).
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 AIT 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 AIT with a p-value of 0.05 and statistical power of 0.90 (primary endpoint is reverse remodeling, assessed by change in left ventricular end-diastolic dimension).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Behavioral: Aerobic Interval Training
    3 weekly sessions of aerobic interval training in 12 weeks
  • Behavioral: Moderate continues training
    3 weekly sessions of moderate continues 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
  • Experimental: 1 Interval training
    Aerobic Interval Training
    Intervention: Behavioral: Aerobic Interval Training
  • Experimental: 2 Moderate Training
    Moderate continues training
    Intervention: Behavioral: Moderate continues training
  • Active Comparator: 3 Recommendation of exercise
    Recommendation of regular exercise at moderate intensity at individual choice
    Intervention: Behavioral: Recommendation of regular moderate exercise
Støylen A, Conraads V, Halle M, Linke A, Prescott E, Ellingsen Ø. Controlled study of myocardial recovery after interval training in heart failure: SMARTEX-HF--rationale and design. Eur J Prev Cardiol. 2012 Aug;19(4):813-21. doi: 10.1177/1741826711403252. Epub 2011 Mar 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
268
June 2014
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Congestive heart failure after myocardial infarction or dilated cardiomyopathy with:

    • LVEF < 0.35,
    • NYHA class II - III,
    • Stable without any signs of worsening for at least 6 weeks,
    • Minimum 3 months of optimal medical treatment,
    • Previous revascularisation or CRT should be more than 6 months before inclusion.

Exclusion Criteria:

  • Significant intercurrent illness last 6 weeks,
  • Known severe ventricular arrhythmia with functional or prognostic significance unless protected with ICD,
  • Significant ischemia,
  • Hemodynamic deterioration or exercise-induced arrhythmia at baseline testing,
  • Other heart disease that limits exercise tolerance (valve disease with significant hemodynamic consequences, hypertrophic cardiomyopathy etc.,
  • Co-morbidity that may significantly influence one-year prognosis,
  • Functional or mental disability that may limit exercise,
  • Patients scheduled for heart transplant at time of inclusion,
  • A habit of regular vigorous exercise or participation in a program of exercise training less than 6 months before inclusion, or participation in another clinical trial,
  • Patients with COPD with FEV1 below 50% of expected values are excluded,
  • Patients taking oral corticosteroids are excluded in all cases.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Denmark,   Germany,   Netherlands,   Norway
 
NCT00917046
090309
Yes
Not Provided
Not Provided
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • University Hospital, Antwerp
  • UMC Utrecht
  • Technische Universität München
  • Heartcenter Leipzig GmbH
  • Bispebjerg Hospital
  • St. Olavs Hospital
  • Helse Stavanger HF
Study Director: Øyvind Ellingsen, MD, PhD NTNU
Norwegian University of Science and Technology
August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP