Heart FailureSMARTEXNCT00917046
The SMARTEX Heart Failure Study
A study testing high-intensity interval training, Moderate continuous training and Recommendation of regular moderate exercise in people with Heart Failure, run by Norwegian University of Science and Technology at 11 sites in 7 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- high-intensity interval training, Moderate continuous training and Recommendation of regular moderate exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 11 sitesin 7 countries
- Study dates
- Jan 2009to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 11Show fewer
- 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.
Trial locations and contacts
11 sites in 7 countries.
11 sites in 7 countries
Norway4 sites
Ålesund Hospital
Ålesund
Levanger Hospital
Levanger
Stavanger University Hospital
Stavanger
St. Olavs University Hospital
Trondheim
Germany2 sites
Universitaet Leipzig, Herzzentrum GmbH
Leipzig
Technische Universitaet Munich
Munich
About this study
Official title: 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).
Read the 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
- Being tested
- high-intensity interval training, Moderate continuous training, Recommendation of regular moderate exercise
- Keywords
- All-cause heart failure patients, coronary artery disease etiology, dilated cardiomyopathy etiology
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-intensity interval trainingBehavioural
3 weekly sessions of high-intensity interval training in 12 weeks
Moderate continuous trainingBehavioural
3 weekly sessions of moderate continuous training for 12 weeks
Recommendation of regular moderate exerciseBehavioural
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 group | Role | What they receive |
|---|---|---|
| 1 Interval training | Experimental | high-intensity Interval Training Receives: Behavioral: high-intensity interval training |
| 2 Moderate Training | Experimental | Moderate continuous training Receives: Behavioral: Moderate continuous training |
| 3 Recommendation of exercise | Active comparator | Recommendation of regular exercise at moderate intensity at individual choice Receives: Behavioral: Recommendation of regular moderate exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks
Measured: Baseline-12 weeks
Secondary outcomes (5)
Exercise capacity
Measured: baseline-12 weeks- 1year
quality of life
Measured: baseline - 12 weeks - 1 year
level of physical activity
Measured: baseline-12 weeks- 1 year
safety and adverse events
Measured: baseline-12 weeks - 1 year
Change in Ejection fraction
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionSep 2013
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, UMC Utrecht, Technical University of Munich, Heart Center Leipzig - University Hospital, Bispebjerg Hospital, St. Olavs Hospital, Helse Stavanger HF, Scientific Institute of Veruno, Centre Hospitalier du Luxembourg, Alesund Hospital, Helse Nord-Trøndelag HF
- Responsible party
- Sponsor
- Investigators
- Øyvind Ellingsen, MD, PhD, Study director, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917046
- Sponsor's protocol ID
- 090309
- Acronym
- SMARTEX
- Status last verified
- Nov 2019
- First submitted
- 8 Jun 2009
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 21450567Ellingsen 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.
PubMed 28082387Karlsen 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.
PubMed 31688648Karlsen T, Vesterbekkmo EK, Hole T, Larsen AI, Valborgland T, Braaten T, Bathen TF, Beckers P, Delagardelle C, Feiereisen P, Craenenbroeck EV, Linke A, Prescott E, Halle M, Ellingsen O, Dalen H. Heart failure etiology and lipoprotein subfractions: Insight from the SMARTEX-HF study. Int J Cardiol Heart Vasc. 2026 Feb 16;63:101888. doi: 10.1016/j.ijcha.2026.101888. eCollection 2026 Apr.
PubMed 41736908Halle M, Prescott E, Van Craenenbroeck EM, Beckers P, Videm V, Karlsen T, Feiereisen P, Winzer EB, Mangner N, Snoer M, Christle JW, Dalen H, Stoylen A, Esefeld K, Heitkamp M, Spanier B, Linke A, Ellingsen O, Delagardelle C; SMARTEX-HF Study Group. Moderate continuous or high intensity interval exercise in heart failure with reduced ejection fraction: Differences between ischemic and non-ischemic etiology. Am Heart J Plus. 2022 Sep 5;22:100202. doi: 10.1016/j.ahjo.2022.100202. eCollection 2022 Oct.
PubMed 38558910Valborgland 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.
PubMed 28097476
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Myocardial Recovery After Exercise Training in Heart Failure
- ClinicalTrials.gov ID
- NCT00917046
- Acronym / sponsor ID
- SMARTEX / 090309
- Conditions
- Heart Failure
- Keywords
- All-cause heart failure patients, coronary artery disease etiology, dilated cardiomyopathy etiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, UMC Utrecht, Technical University of Munich, Heart Center Leipzig - University Hospital, Bispebjerg Hospital, St. Olavs Hospital, Helse Stavanger HF, Scientific Institute of Veruno, Centre Hospitalier du Luxembourg, Alesund Hospital, Helse Nord-Trøndelag HF
- Study start
- Jan 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 Interval training | Experimental | Behavioral: high-intensity interval traininghigh-intensity Interval Training |
| 2 Moderate Training | Experimental | Behavioral: Moderate continuous trainingModerate continuous training |
| 3 Recommendation of exercise | Active comparator | Behavioral: Recommendation of regular moderate exerciseRecommendation of regular exercise at moderate intensity at individual choice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Congestive heart failure after myocardial infarction or dilated cardiomyopathy with:
Key exclusion criteria (11 listed)
- 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.,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-intensity interval training3 weekly sessions of high-intensity interval training in 12 weeks | Behavioural | 1 Interval training |
| Moderate continuous training3 weekly sessions of moderate continuous training for 12 weeks | Behavioural | 2 Moderate Training |
| Recommendation of regular moderate exerciseRecommendation 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 | Behavioural | 3 Recommendation of exercise |
Primary outcome
comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks
Time frame: Baseline-12 weeks
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Background: PubMed 21450567Stoylen 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.
- Results publication: PubMed 28082387Ellingsen 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.
- Results publication: PubMed 31688648Karlsen 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.
- Derived from this study: PubMed 41736908Karlsen T, Vesterbekkmo EK, Hole T, Larsen AI, Valborgland T, Braaten T, Bathen TF, Beckers P, Delagardelle C, Feiereisen P, Craenenbroeck EV, Linke A, Prescott E, Halle M, Ellingsen O, Dalen H. Heart failure etiology and lipoprotein subfractions: Insight from the SMARTEX-HF study. Int J Cardiol Heart Vasc. 2026 Feb 16;63:101888. doi: 10.1016/j.ijcha.2026.101888. eCollection 2026 Apr.
- Derived from this study: PubMed 38558910Halle M, Prescott E, Van Craenenbroeck EM, Beckers P, Videm V, Karlsen T, Feiereisen P, Winzer EB, Mangner N, Snoer M, Christle JW, Dalen H, Stoylen A, Esefeld K, Heitkamp M, Spanier B, Linke A, Ellingsen O, Delagardelle C; SMARTEX-HF Study Group. Moderate continuous or high intensity interval exercise in heart failure with reduced ejection fraction: Differences between ischemic and non-ischemic etiology. Am Heart J Plus. 2022 Sep 5;22:100202. doi: 10.1016/j.ahjo.2022.100202. eCollection 2022 Oct.
- Derived from this study: PubMed 28097476Valborgland 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Øyvind Ellingsen, MD, PhD study director
National Taiwan Normal University
11 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-intensity interval training, Moderate continuous training and Recommendation of regular moderate exercise in people with Heart Failure, run by Norwegian University of Science and Technology at 11 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Norway, Germany, Belgium, Denmark, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks (time frame: Baseline-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00917046, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2019.