The SMARTEX Heart Failure Study

NCT ID: NCT00917046

Last Updated: 2019-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2014-07-31

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).

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1 Interval training

high-intensity Interval Training

Group Type: EXPERIMENTAL

high-intensity interval training

Intervention Type: BEHAVIORAL

3 weekly sessions of high-intensity interval training in 12 weeks

2 Moderate Training

Moderate continuous training

Group Type: EXPERIMENTAL

Moderate continuous training

Intervention Type: BEHAVIORAL

3 weekly sessions of moderate continuous training for 12 weeks

3 Recommendation of exercise

Recommendation of regular exercise at moderate intensity at individual choice

Group Type: ACTIVE_COMPARATOR

Recommendation of regular moderate exercise

Intervention Type: BEHAVIORAL

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

Interventions

high-intensity interval training

3 weekly sessions of high-intensity interval training in 12 weeks

Intervention Type: BEHAVIORAL

Moderate continuous training

3 weekly sessions of moderate continuous training for 12 weeks

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

UMC Utrecht

OTHER

Sponsor Role: collaborator

Technical University of Munich

OTHER

Sponsor Role: collaborator

Heart Center Leipzig - University Hospital

OTHER

Sponsor Role: collaborator

Bispebjerg Hospital

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role: collaborator

Scientific Institute of Veruno

UNKNOWN

Sponsor Role: collaborator

Centre Hospitalier du Luxembourg

OTHER

Sponsor Role: collaborator

Alesund Hospital

OTHER

Sponsor Role: collaborator

Helse Nord-Trøndelag HF

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Øyvind Ellingsen, MD, PhD

Role: STUDY_DIRECTOR

National Taiwan Normal University

Locations

University Hospital Antwerp

Antwerp, , Belgium

Bispebjerg University Hospital

Copenhagen, , Denmark

Universitaet Leipzig, Herzzentrum GmbH

Leipzig, , Germany

Technische Universitaet Munich

Munich, , Germany

Scientific Institute of Veruno

Veruno, , Italy

Centre Hospitaliers de Luxembourg

Luxembourg, , Luxembourg

University Medical Center Utrecht

Utrecht, , Netherlands

Ålesund Hospital

Ålesund, , Norway

Levanger Hospital

Levanger, , Norway

Stavanger University Hospital

Stavanger, , Norway

St. Olavs University Hospital

Trondheim, , Norway

Countries

Belgium; Denmark; Germany; Italy; Luxembourg; Netherlands; Norway

References

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.

Reference Type: BACKGROUND

PMID: 21450567 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28082387 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31688648 (View on PubMed)

Halle 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.

Reference Type: DERIVED

PMID: 38558910 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28097476 (View on PubMed)

Other Identifiers

090309

Identifier Type: -

Identifier Source: org_study_id