Clinical trial NCT00917046: The SMARTEX Heart Failure Study
Official title: Study of Myocardial Recovery After Exercise Training in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: All-cause heart failure patients
coronary artery disease etiology
dilated cardiomyopathy etiology
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: University Hospital, Antwerp
name: UMC Utrecht
name: Technical University of Munich
name: Heart Center Leipzig - University Hospital
name: Bispebjerg Hospital
name: St. Olavs Hospital
name: Helse Stavanger HF
name: Scientific Institute of Veruno
name: Centre Hospitalier du Luxembourg
name: Alesund Hospital
name: Helse Nord-Trøndelag HF
First posted: 2009-06-10
Enrollment: 261
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks
timeFrame: Baseline-12 weeks
Secondary outcomes:
measure: Exercise capacity
timeFrame: baseline-12 weeks- 1year
measure: quality of life
timeFrame: baseline - 12 weeks - 1 year
measure: level of physical activity
timeFrame: baseline-12 weeks- 1 year
measure: safety and adverse events
timeFrame: baseline-12 weeks - 1 year
measure: Change in Ejection fraction
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: University Hospital Antwerp
city: Copenhagen
country: Denmark
facility: Bispebjerg University Hospital
city: Leipzig
country: Germany
facility: Universitaet Leipzig, Herzzentrum GmbH
city: Munich
country: Germany
facility: Technische Universitaet Munich
city: Veruno
country: Italy
facility: Scientific Institute of Veruno
city: Luxembourg
country: Luxembourg
facility: Centre Hospitaliers de Luxembourg
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Alesund
country: Norway
facility: Ålesund Hospital
city: Levanger
country: Norway
facility: Levanger Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: National Taiwan Normal University
name: Øyvind Ellingsen, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.