The SMARTEX Heart Failure Study (SMARTEX)
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ClinicalTrials.gov Identifier: NCT00917046 |
Recruitment Status
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Completed
First Posted
: June 10, 2009
Last Update Posted
: January 18, 2017
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Sponsor:
Norwegian University of Science and Technology
Collaborators:
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
Information provided by (Responsible Party):
Norwegian University of Science and Technology
Tracking Information | ||||
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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 |
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 |
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 |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Heart Failure | |||
Intervention ICMJE |
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Study Arms |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
261 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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Responsible Party | Norwegian University of Science and Technology | |||
Study Sponsor ICMJE | Norwegian University of Science and Technology | |||
Collaborators ICMJE |
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Investigators ICMJE |
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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 |