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The SMARTEX Heart Failure Study (SMARTEX)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
high-intensity interval training
Moderate continuous training
Recommendation of regular moderate exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring All-cause heart failure patients, coronary artery disease etiology, dilated cardiomyopathy etiology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Antwerp
  • Bispebjerg University Hospital
  • Universitaet Leipzig, Herzzentrum GmbH
  • Technische Universitaet Munich
  • Scientific Institute of Veruno
  • Centre Hospitaliers de Luxembourg
  • University Medical Center Utrecht
  • Ålesund Hospital
  • Levanger Hospital
  • Stavanger University Hospital
  • St. Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1 Interval training

2 Moderate Training

3 Recommendation of exercise

Arm Description

high-intensity Interval Training

Moderate continuous training

Recommendation of regular exercise at moderate intensity at individual choice

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Exercise capacity
quality of life
level of physical activity
safety and adverse events
Change in Ejection fraction

Full Information

First Posted
June 8, 2009
Last Updated
November 12, 2019
Sponsor
Norwegian University of Science and Technology
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
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1. Study Identification

Unique Protocol Identification Number
NCT00917046
Brief Title
The SMARTEX Heart Failure Study
Acronym
SMARTEX
Official Title
Study of Myocardial Recovery After Exercise Training in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
All-cause heart failure patients, coronary artery disease etiology, dilated cardiomyopathy etiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Interval training
Arm Type
Experimental
Arm Description
high-intensity Interval Training
Arm Title
2 Moderate Training
Arm Type
Experimental
Arm Description
Moderate continuous training
Arm Title
3 Recommendation of exercise
Arm Type
Active Comparator
Arm Description
Recommendation of regular exercise at moderate intensity at individual choice
Intervention Type
Behavioral
Intervention Name(s)
high-intensity interval training
Intervention Description
3 weekly sessions of high-intensity interval training in 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Moderate continuous training
Intervention Description
3 weekly sessions of moderate continuous training for 12 weeks
Intervention Type
Behavioral
Intervention Name(s)
Recommendation of regular moderate exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks
Time Frame
Baseline-12 weeks
Secondary Outcome Measure Information:
Title
Exercise capacity
Time Frame
baseline-12 weeks- 1year
Title
quality of life
Time Frame
baseline - 12 weeks - 1 year
Title
level of physical activity
Time Frame
baseline-12 weeks- 1 year
Title
safety and adverse events
Time Frame
baseline-12 weeks - 1 year
Title
Change in Ejection fraction
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Øyvind Ellingsen, MD, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Antwerp
City
Antwerp
Country
Belgium
Facility Name
Bispebjerg University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Universitaet Leipzig, Herzzentrum GmbH
City
Leipzig
Country
Germany
Facility Name
Technische Universitaet Munich
City
Munich
Country
Germany
Facility Name
Scientific Institute of Veruno
City
Veruno
Country
Italy
Facility Name
Centre Hospitaliers de Luxembourg
City
Luxembourg
Country
Luxembourg
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Facility Name
Ålesund Hospital
City
Alesund
Country
Norway
Facility Name
Levanger Hospital
City
Levanger
Country
Norway
Facility Name
Stavanger University Hospital
City
Stavanger
Country
Norway
Facility Name
St. Olavs University Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21450567
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.
Results Reference
background
PubMed Identifier
28082387
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.
Results Reference
result
PubMed Identifier
31688648
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.
Results Reference
result
PubMed Identifier
28097476
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.
Results Reference
derived

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The SMARTEX Heart Failure Study

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