The SMARTEX Heart Failure Study (SMARTEX)

Study of Myocardial Recovery After Exercise Training in Heart Failure

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).

Study Overview

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 Type

Interventional

Enrollment (Actual)

261

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Antwerp, Belgium
        • University Hospital Antwerp
      • Copenhagen, Denmark
        • Bispebjerg University Hospital
      • Leipzig, Germany
        • Universitaet Leipzig, Herzzentrum GmbH
      • Munich, Germany
        • Technische Universitaet Munich
      • Veruno, Italy
        • Scientific Institute of Veruno
      • Luxembourg, Luxembourg
        • Centre Hospitaliers de Luxembourg
      • Utrecht, Netherlands
        • University Medical Center Utrecht
      • Alesund, Norway
        • Ålesund Hospital
      • Levanger, Norway
        • Levanger Hospital
      • Stavanger, Norway
        • Stavanger University Hospital
      • Trondheim, Norway
        • St. Olavs University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 Interval training
high-intensity Interval Training
3 weekly sessions of high-intensity interval training in 12 weeks
Experimental: 2 Moderate Training
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks
Time Frame: Baseline-12 weeks
Baseline-12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Exercise capacity
Time Frame: baseline-12 weeks- 1year
baseline-12 weeks- 1year
quality of life
Time Frame: baseline - 12 weeks - 1 year
baseline - 12 weeks - 1 year
level of physical activity
Time Frame: baseline-12 weeks- 1 year
baseline-12 weeks- 1 year
safety and adverse events
Time Frame: baseline-12 weeks - 1 year
baseline-12 weeks - 1 year
Change in Ejection fraction
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

June 9, 2009

First Posted (Estimate)

June 10, 2009

Study Record Updates

Last Update Posted (Actual)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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