We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

The SMARTEX Heart Failure Study (SMARTEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00917046
Recruitment Status : Completed
First Posted : June 10, 2009
Last Update Posted : January 18, 2017
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment
Heart Failure Behavioral: high-intensity interval training Behavioral: Moderate continuous training Behavioral: Recommendation of regular moderate exercise

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 261 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Myocardial Recovery After Exercise Training in Heart Failure
Study Start Date : January 2009
Primary Completion Date : September 2013
Study Completion Date : July 2014

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Interval training
high-intensity Interval Training
Behavioral: high-intensity interval training
3 weekly sessions of high-intensity interval training in 12 weeks
Experimental: 2 Moderate Training
Moderate continuous training
Behavioral: Moderate continuous training
3 weekly sessions of moderate continuous training for 12 weeks
Active Comparator: 3 Recommendation of exercise
Recommendation of regular exercise at moderate intensity at individual choice
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

Outcome Measures

Primary Outcome Measures :
  1. comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks [ Time Frame: Baseline-12 weeks ]

Secondary Outcome Measures :
  1. Exercise capacity [ Time Frame: baseline-12 weeks- 1year ]
  2. quality of life [ Time Frame: baseline - 12 weeks - 1 year ]
  3. level of physical activity [ Time Frame: baseline-12 weeks- 1 year ]
  4. safety and adverse events [ Time Frame: baseline-12 weeks - 1 year ]
  5. Change in Ejection fraction [ Time Frame: 12 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00917046

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
Alesund, Norway
Levanger Hospital
Levanger, Norway
Stavanger University Hospital
Stavanger, Norway
St. Olavs University Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
University Hospital, Antwerp
UMC Utrecht
Technische Universität München
Heartcenter Leipzig GmbH
Bispebjerg Hospital
St. Olavs Hospital
Helse Stavanger HF
Scientific Institute of Veruno
Centre Hospitalier du Luxembourg
Alesund Hospital
Levanger Hospital
Study Director: Øyvind Ellingsen, MD, PhD NTNU
More Information

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00917046     History of Changes
Other Study ID Numbers: 090309
First Posted: June 10, 2009    Key Record Dates
Last Update Posted: January 18, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Norwegian University of Science and Technology:
All-cause heart failure patients
coronary artery disease etiology
dilated cardiomyopathy etiology

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases