The SMARTEX Heart Failure Study (SMARTEX)

This study has been completed.

Sponsor:

Collaborators:

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

Information provided by (Responsible Party):

Norwegian University of Science and Technology

ClinicalTrials.gov Identifier:

NCT00917046

First received: June 8, 2009

Last updated: January 16, 2017

Last verified: November 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

June 8, 2009

Last Updated Date

January 16, 2017

Start Date ^ICMJE

January 2009

Primary Completion Date

September 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Cardiac volumes and functions (reverse remodeling and improved left ventricular function) [ Time Frame: Baseline-12 weeks- 1 year ]

Change History

Complete list of historical versions of study NCT00917046 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Exercise capacity [ Time Frame: baseline-12 weeks- 1year ]
quality of life [ Time Frame: baseline - 12 weeks - 1 year ]
level of physical activity [ Time Frame: baseline-12 weeks- 1 year ]
safety and adverse events [ Time Frame: baseline-12 weeks - 1 year ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

The SMARTEX Heart Failure Study

Official Title ^ICMJE

Study of Myocardial Recovery After Exercise Training in Heart Failure

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).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Heart Failure

Intervention ^ICMJE

Behavioral: high-intensity interval training
3 weekly sessions of high-intensity interval training in 12 weeks
Behavioral: Moderate continuous training
3 weekly sessions of moderate continuous training for 12 weeks
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

Study Arms

Experimental: 1 Interval training
high-intensity Interval Training

Intervention: Behavioral: high-intensity interval training
Experimental: 2 Moderate Training
Moderate continuous training

Intervention: Behavioral: Moderate continuous training
Active Comparator: 3 Recommendation of exercise
Recommendation of regular exercise at moderate intensity at individual choice

Intervention: Behavioral: Recommendation of regular moderate exercise

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

261

Completion Date

July 2014

Primary Completion Date

September 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Belgium, Denmark, Germany, Italy, Luxembourg, Netherlands, Norway

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00917046

Other Study ID Numbers ^ICMJE

090309

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Norwegian University of Science and Technology

Study Sponsor ^ICMJE

Norwegian University of Science and Technology

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Director:

Øyvind Ellingsen, MD, PhD

NTNU

PRS Account

Norwegian University of Science and Technology

Verification Date

November 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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