- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00917046
The SMARTEX Heart Failure Study (SMARTEX)
November 12, 2019 updated by: Norwegian University of Science and Technology
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 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).
Study Overview
Status
Completed
Conditions
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
Interventional
Enrollment (Actual)
261
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antwerp, Belgium
- University Hospital Antwerp
-
-
-
-
-
Copenhagen, Denmark
- Bispebjerg University Hospital
-
-
-
-
-
Leipzig, Germany
- Universitaet Leipzig, Herzzentrum GmbH
-
Munich, Germany
- Technische Universitaet Munich
-
-
-
-
-
Veruno, Italy
- Scientific Institute of Veruno
-
-
-
-
-
Luxembourg, Luxembourg
- Centre Hospitaliers de Luxembourg
-
-
-
-
-
Utrecht, Netherlands
- University Medical Center Utrecht
-
-
-
-
-
Alesund, Norway
- Ålesund Hospital
-
Levanger, Norway
- Levanger Hospital
-
Stavanger, Norway
- Stavanger University Hospital
-
Trondheim, Norway
- St. Olavs University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1 Interval training
high-intensity Interval Training
|
3 weekly sessions of high-intensity interval training in 12 weeks
|
Experimental: 2 Moderate Training
Moderate continuous training
|
3 weekly sessions of moderate continuous training for 12 weeks
|
Active Comparator: 3 Recommendation of exercise
Recommendation of regular exercise at moderate intensity at individual choice
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks
Time Frame: Baseline-12 weeks
|
Baseline-12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exercise capacity
Time Frame: baseline-12 weeks- 1year
|
baseline-12 weeks- 1year
|
quality of life
Time Frame: baseline - 12 weeks - 1 year
|
baseline - 12 weeks - 1 year
|
level of physical activity
Time Frame: baseline-12 weeks- 1 year
|
baseline-12 weeks- 1 year
|
safety and adverse events
Time Frame: baseline-12 weeks - 1 year
|
baseline-12 weeks - 1 year
|
Change in Ejection fraction
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Øyvind Ellingsen, MD, PhD, National Taiwan Normal University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Stoylen A, Conraads V, Halle M, Linke A, Prescott E, Ellingsen O. 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 O, Halle M, Conraads V, Stoylen 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, Hollriegel 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.
- Karlsen T, Videm V, Halle M, Ellingsen O, Stoylen A, Dalen H, Delagardelle C, Larsen AI, Hole T, Mezzani A, VAN Craenenbroeck EM, Beckers P, Pressler A, Christle JW, Winzer EB, Mangner N, Woitek FJ, Hollriegel R, Snoer M, Feiereisen P, Valborgland T, Linke A, Prescott E. Baseline and Exercise Predictors of V O2peak in Systolic Heart Failure Patients: Results from SMARTEX-HF. Med Sci Sports Exerc. 2020 Apr;52(4):810-819. doi: 10.1249/MSS.0000000000002193.
- Valborgland T, Isaksen K, Munk PS, Grabowski ZP, Larsen AI. Impact of an exercise training program on cardiac neuronal function in heart failure patients on optimal medical therapy : A randomized Iodine-123 metaiodobenzylguanidine scintigraphy study. J Nucl Cardiol. 2018 Aug;25(4):1164-1171. doi: 10.1007/s12350-016-0724-8. Epub 2017 Jan 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
June 8, 2009
First Submitted That Met QC Criteria
June 9, 2009
First Posted (Estimate)
June 10, 2009
Study Record Updates
Last Update Posted (Actual)
November 14, 2019
Last Update Submitted That Met QC Criteria
November 12, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 090309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Failure
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
University Hospital, MontpellierCompletedHeart Failure | Diastolic Heart Failure | Systolic Heart Failure Stage CFrance
-
Lancaster General HospitalLouise von Hess Medical Research InstituteEnrolling by invitationDiastolic Heart FailureUnited States
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Giresun UniversityIstanbul University - Cerrahpasa (IUC)RecruitingHeart Failure | Diastolic Heart Failure | Systolic Heart FailureTurkey
-
US Department of Veterans AffairsCompleted
Clinical Trials on high-intensity interval training
-
University of MichiganCompletedGlucose IntoleranceUnited States
-
Universidad SurcolombianaMaciste Macias; Gilberto AstaizaRecruiting
-
Kuopio Research Institute of Exercise MedicineKuopio University Hospital; University of Basel; University of Eastern Finland; Social Insurance Institution, FinlandTerminatedUnstable Angina Pectoris | Acute Myocardial Infarction | Recurrent Myocardial InfarctionFinland
-
Cairo UniversityKasr El Aini HospitalCompletedDiabetes Mellitus, Type 2Egypt
-
Universidad Santo TomasCompletedMetabolic DiseasesColombia
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Liverpool John Moores University; Australian Catholic UniversityCompletedPolycystic Ovary SyndromeAustralia, Norway
-
Norwegian University of Science and TechnologySt. Olavs Hospital; Liverpool John Moores University; Australian Catholic UniversityCompletedPolycystic Ovary SyndromeAustralia, Norway
-
Université de SherbrookeRecruiting
-
Hunter College of City University of New YorkRecruiting
-
Mayo ClinicRecruitingCardiac RehabilitationUnited States