The SMARTEX Heart Failure Study

Heart Failure Clinical Trial

— SMARTEX  

Official title:

Study of Myocardial Recovery After Exercise Training in Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00917046
• Other study ID #: 090309
• Status: Completed
• Phase: N/A
• Start date: January 2009
• Est. completion date: July 2014

Study information

• Verified date: November 2019
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 261
• Est. completion date: July 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

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

Sponsors (12)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Alesund Hospital, Bispebjerg Hospital, Centre Hospitalier du Luxembourg, Heart Center Leipzig - University Hospital, Helse Stavanger HF, Levanger Hospital, Scientific Institute of Veruno, St. Olavs Hospital, Technische Universität München, UMC Utrecht, University Hospital, Antwerp

Countries where clinical trial is conducted

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

References & Publications (3)

Ellingsen Ø, Halle M, Conraads V, Støylen A, Dalen H, Delagardelle C, Larsen AI, Hole T, Mezzani A, Van Craenenbroeck EM, Videm V, Beckers P, Christle JW, Winzer E, Mangner N, Woitek F, Höllriegel R, Pressler A, Monk-Hansen T, Snoer M, Feiereisen P, Valbo — View Citation

Karlsen T, Videm V, Halle M, Ellingsen Ø, Støylen A, Dalen H, Delagardelle C, Larsen AI, Hole T, Mezzani A, Van Craenenbroeck EM, Beckers P, Pressler A, Christle JW, Winzer E, Mangner N, Woitek F, Höllriegel R, Snoer M, Feiereisen P, Valborgland T, Linke — View Citation

Støylen A, Conraads V, Halle M, Linke A, Prescott E, Ellingsen Ø. Controlled study of myocardial recovery after interval training in heart failure: SMARTEX-HF--rationale and design. Eur J Prev Cardiol. 2012 Aug;19(4):813-21. doi: 10.1177/1741826711403252. Epub 2011 Mar 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparison between groups in change of left ventricular end diastolic diameter from baseline to 12 weeks		Baseline-12 weeks
Secondary	Exercise capacity		baseline-12 weeks- 1year
Secondary	quality of life		baseline - 12 weeks - 1 year
Secondary	level of physical activity		baseline-12 weeks- 1 year
Secondary	safety and adverse events		baseline-12 weeks - 1 year
Secondary	Change in Ejection fraction		12 weeks