Status:
COMPLETED
The SMARTEX Heart Failure Study
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
University Hospital, Antwerp
UMC Utrecht
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 st...
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 q...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
261 Patients enrolled
Trial Details
Trial ID
NCT00917046
Start Date
January 1 2009
End Date
July 1 2014
Last Update
November 14 2019
Active Locations (11)
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1
University Hospital Antwerp
Antwerp, Belgium
2
Bispebjerg University Hospital
Copenhagen, Denmark
3
Universitaet Leipzig, Herzzentrum GmbH
Leipzig, Germany
4
Technische Universitaet Munich
Munich, Germany