The SMARTEX Heart Failure Study (SMARTEX)

Tracking Information
First Submitted Date ICMJE	June 8, 2009
First Posted Date ICMJE	June 10, 2009
Last Update Posted Date	January 18, 2017
Study Start Date ICMJE	January 2009
Actual Primary Completion Date	September 2013 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 11, 2016)	comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks [ Time Frame: Baseline-12 weeks ]
Original Primary Outcome Measures ICMJE; (submitted: June 9, 2009)	Cardiac volumes and functions (reverse remodeling and improved left ventricular function) [ Time Frame: Baseline-12 weeks- 1 year ]
Change History	Complete list of historical versions of study NCT00917046 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: August 19, 2016)	Exercise capacity [ Time Frame: baseline-12 weeks- 1year ]; quality of life [ Time Frame: baseline - 12 weeks - 1 year ]; level of physical activity [ Time Frame: baseline-12 weeks- 1 year ]; safety and adverse events [ Time Frame: baseline-12 weeks - 1 year ]; Change in Ejection fraction [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures ICMJE; (submitted: June 9, 2009)	Exercise capacity [ Time Frame: baseline-12 weeks- 1year ]; quality of life [ Time Frame: baseline - 12 weeks - 1 year ]; level of physical activity [ Time Frame: baseline-12 weeks- 1 year ]; safety and adverse events [ Time Frame: baseline-12 weeks - 1 year ]
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	The SMARTEX Heart Failure Study
Official Title ICMJE	Study of Myocardial Recovery After Exercise Training in Heart Failure
Brief 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).
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Heart Failure
Intervention ICMJE	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
Study Arms	Experimental: 1 Interval training high-intensity Interval Training Intervention: Behavioral: high-intensity interval training; Experimental: 2 Moderate Training Moderate continuous training Intervention: Behavioral: Moderate continuous training; Active Comparator: 3 Recommendation of exercise Recommendation of regular exercise at moderate intensity at individual choice Intervention: Behavioral: Recommendation of regular moderate exercise
Publications *	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.; Ellingsen Ø, Halle M, Conraads V, Støylen A, Dalen H, Delagardelle C, Larsen AI, Hole T, Mezzani A, Van Craenenbroeck EM, Videm V, Beckers P, Christle JW, Winzer E, Mangner N, Woitek F, Höllriegel R, Pressler A, Monk-Hansen T, Snoer M, Feiereisen P, Valborgland T, Kjekshus J, Hambrecht R, Gielen S, Karlsen T, Prescott E, Linke A; SMARTEX Heart Failure Study (Study of Myocardial Recovery After Exercise Training in Heart Failure) Group. High-Intensity Interval Training in Patients With Heart Failure With Reduced Ejection Fraction. Circulation. 2017 Feb 28;135(9):839-849. doi: 10.1161/CIRCULATIONAHA.116.022924. Epub 2017 Jan 12.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 11, 2016)	261
Original Estimated Enrollment ICMJE; (submitted: June 9, 2009)	200
Actual Study Completion Date	July 2014
Actual Primary Completion Date	September 2013 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Belgium, Denmark, Germany, Italy, Luxembourg, Netherlands, Norway
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00917046
Other Study ID Numbers ICMJE	090309
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Norwegian University of Science and Technology
Study Sponsor ICMJE	Norwegian University of Science and Technology
Collaborators ICMJE	University Hospital, Antwerp; UMC Utrecht; Technische Universität München; Heartcenter Leipzig GmbH; Bispebjerg Hospital; St. Olavs Hospital; Helse Stavanger HF; Scientific Institute of Veruno; Centre Hospitalier du Luxembourg; Alesund Hospital; Levanger Hospital
Investigators ICMJE	Study Director: Øyvind Ellingsen, MD, PhD NTNU
PRS Account	Norwegian University of Science and Technology
Verification Date	November 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP