The SMARTEX Heart Failure Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University Hospital, Antwerp
UMC Utrecht
Technische Universität München
Universität Leipzig, Herzzentrum Gmbh
Bispebjerg Hospital
St. Olavs Hospital
Helse Stavanger HF
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00917046
First received: June 8, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

This protocol describes a randomized multicenter clinical trial designed to test the hypothesis that a 12-week program of aerobic interval training (AIT) 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 Intervention
Heart Failure
Behavioral: Aerobic Interval Training
Behavioral: Moderate continues training
Behavioral: Recommendation of regular moderate exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Myocardial Recovery After Exercise Training in Heart Failure

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Cardiac volumes and functions (reverse remodeling and improved left ventricular function) [ Time Frame: Baseline-12 weeks- 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exercise capacity [ Time Frame: baseline-12 weeks- 1year ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: baseline - 12 weeks - 1 year ] [ Designated as safety issue: No ]
  • level of physical activity [ Time Frame: baseline-12 weeks- 1 year ] [ Designated as safety issue: No ]
  • safety and adverse events [ Time Frame: baseline-12 weeks - 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: January 2009
Estimated Study Completion Date: June 2014
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Interval training
Aerobic Interval Training
Behavioral: Aerobic Interval Training
3 weekly sessions of aerobic interval training in 12 weeks
Experimental: 2 Moderate Training
Moderate continues training
Behavioral: Moderate continues training
3 weekly sessions of moderate continues 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

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 AIT 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 AIT with a p-value of 0.05 and statistical power of 0.90 (primary endpoint is reverse remodeling, assessed by change in left ventricular end-diastolic dimension).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00917046

Locations
Belgium
University Hospital Antwerp
Antwerp, Belgium
Denmark
Bispebjerg University Hospital
Copenhagen, Denmark
Germany
Universitaet Leipzig, Herzzentrum GmbH
Leipzig, Germany
Technische Universitaet Munich
Munich, Germany
Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
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
Universität Leipzig, Herzzentrum Gmbh
Bispebjerg Hospital
St. Olavs Hospital
Helse Stavanger HF
Investigators
Study Director: Øyvind Ellingsen, MD, PhD NTNU
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00917046     History of Changes
Other Study ID Numbers: 090309
Study First Received: June 8, 2009
Last Updated: November 18, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics
Germany: Ethics Commission
Norway: Norwegian Institute of Public Health
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics

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

ClinicalTrials.gov processed this record on August 21, 2014