The SMARTEX Heart Failure Study

NCT00917046 | Completed DMC

• 1 other identifier: 090309
• Study Type: interventional
• Target: 261
• Locations: 7 countries
• Sites: 11

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).

Conditions

Heart Failure

Keywords

All-cause heart failure patients; coronary artery disease etiology; dilated cardiomyopathy etiology

Outcome Measures

Primary Outcomes (1)

• comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks

  Baseline-12 weeks

Secondary Outcomes (5)

• Exercise capacity

  baseline-12 weeks- 1year

• quality of life

  baseline - 12 weeks - 1 year

• level of physical activity

  baseline-12 weeks- 1 year

• safety and adverse events

  baseline-12 weeks - 1 year

• Change in Ejection fraction

  12 weeks

Study Arms (3)

1 Interval training

EXPERIMENTAL

high-intensity Interval Training

Behavioral: high-intensity interval training

2 Moderate Training

EXPERIMENTAL

Moderate continuous training

Behavioral: Moderate continuous training

3 Recommendation of exercise

ACTIVE COMPARATOR

Recommendation of regular exercise at moderate intensity at individual choice

Behavioral: Recommendation of regular moderate exercise

Interventions

high-intensity interval training BEHAVIORAL

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

1 Interval training

Moderate continuous training BEHAVIORAL

3 weekly sessions of moderate continuous training for 12 weeks

2 Moderate Training

Recommendation of regular moderate exercise 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

3 Recommendation of exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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 with COPD with FEV1 below 50% of expected values are excluded,
• Patients taking oral corticosteroids are excluded in all cases.

Sponsors & Collaborators

• Norwegian University of Science and Technology: lead
• University Hospital, Antwerp: collaborator
• UMC Utrecht: collaborator
• Technical University of Munich: collaborator
• Heart Center Leipzig - University Hospital: collaborator
• Bispebjerg Hospital: collaborator
• St. Olavs Hospital: collaborator
• Helse Stavanger HF: collaborator
• Scientific Institute of Veruno: collaborator
• Centre Hospitalier du Luxembourg: collaborator
• Alesund Hospital: collaborator
• Helse Nord-Trøndelag HF: collaborator

Study Sites (11)

University Hospital Antwerp

Antwerp, Belgium

Location

Bispebjerg University Hospital

Copenhagen, Denmark

Location

Universitaet Leipzig, Herzzentrum GmbH

Leipzig, Germany

Location

Technische Universitaet Munich

Munich, Germany

Location

Scientific Institute of Veruno

Veruno, Italy

Location

Centre Hospitaliers de Luxembourg

Luxembourg, Luxembourg

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Ålesund Hospital

Ålesund, Norway

Location

Levanger Hospital

Levanger, Norway

Location

Stavanger University Hospital

Stavanger, Norway

Location

St. Olavs University Hospital

Trondheim, Norway

Location

Related Publications (5)

• 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.

  PMID: 21450567 BACKGROUND

• 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.

  PMID: 28082387 RESULT

• 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.

  PMID: 31688648 RESULT

• 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.

  PMID: 38558910 DERIVED

• 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.

  PMID: 28097476 DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Øyvind Ellingsen, MD, PhD

  National Taiwan Normal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: June 10, 2009
• Study Start: January 1, 2009
• Primary Completion: September 1, 2013
• Study Completion: July 1, 2014
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); IT (1); NL (1); NO (4); DE (2); LU (1); DK (1)