Exercise Training in Patients With Cardioverter-Defibrillators (BETA)

Study Description

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Brief Summary:

Exercise therapy has proven to be an effective additive therapy in patients with cardiovascular diseases. The prognostic value of physical activity is well established in patients with congestive heart failure. Therefore the investigators assumed that the population of patients with implantable cardioverter-defibrillators (ICD) with impaired left ventricular function may also benefit from a cardiovascular training in terms of improved quality of life and reduction of ventricular arrhythmia. The data on feasibility, risk and therapeutic effects of exercise training are very limited or not available.

This prospective randomized study examines the feasibility and benefits of exercise therapy in patients with ICD and congestive heart failure.

Condition or disease	Intervention/treatment	Phase
Arrhythmia	Behavioral: exercise training	Not Applicable

Detailed Description:

Detailed anamnesis and a clinical examination will be performed in order to determine the patient's eligibility for the study. The randomisation either to the exercise- or to the control-arm will be performed at baseline. Follow-up visits are planned after four weeks and after three months same for both arms. The close-up visit is planned after 6 months.

The exercise-arm starts off with an introduction into physical training at the Department of Sports Medicine at the University in Tübingen. Ergospirometry and 6-min walk test will be performed to determine the patients' performance. Then the patients will be encouraged to exercise at home. The scales and intensities of physical training will vary interpersonally depending on patients individual performance. Pedometers and the ICD-integrated "Cardiac Compass" function will be used to verify work load, intensity and duration of the physical strain. The patients will be consulted by telephone regularly to affirm the study compliance. The physical activity in the control-arm will be monitored using the ICD-integrated "Cardiac Compass" function.

ICD-programming

• VT/SVT discrimination "on",
• "Cardiac Compass" feature "on"
• VT/VF detection and pacing-programming remain adjusted to clinical situation of the patient

Baseline- and follow-up visits

• Anamnesis, NYHA-stadium, patients' demographic data: sex, age, weight, hight, concomitant diseases and current medication
• Clinical examination: weight, inflow-congestion, edema, pulmonary signs of cardiac decompensation
• Chest- x-ray (baseline, 6 moths FU)
• 6-min walk test (baseline, 6 moths FU)
• Blood take (baseline, 6 moths FU) standard examinations including blood morphology, troponin, renal retention parameters, transaminases)
• Determination of the BNP plasma level
• Echocardiography (baseline, 6 moths FU): left-ventricular function (EF) and diameter, valvular function, estimating of systolic pulmonary arterial pressure (PAP sys.).
• Ergospirometry (baseline, 6 moths FU):peak-oxygen-uptake-volume, starting at 10 Watt with increase of the work load 12 Watts per minute until the work load capacity has been reached. The achieved VO2 value is defined as the 100 % oxygen-uptake. At home the patients are supposed to exercise at about 70 % of their VO2 peak.
• Measurement/Recording of the peripheral oxygen-uptake of the muscle with near-infrared-spectroscopy simultaneously with the bicycle-ergometric exposure.
• Complete interrogation of the ICD-memory, acquisition of the "Cardiac-Compass"-data, sensing- and threshold-test, recording of electrical impedance and checking of the battery-status, impedance and checking of the battery-status
• Acquisition of the standardized questionnaires concerning quality-of-life, personality, depression and anxiety: PHQ-D, DS14, FSGV 1.0 and GAD-7.

Definition of adverse event

• Adverse event (AE): Any decrease of existential orientation, unwanted incidence, subjective or objective symptom of any kind of disease, impairment or any accident, that may or may not be connected to the study is defined as an (AE).
• Severe adverse event (SAE): A SAE is an event which is life-threatening or deadly, causes significant or chronic damage, requires hospitalization or threatens the patient's physical inviolability in any other way.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	BETA: Beneficial Effects of Exercise Training in Patients With Implantable Cardioverter-Defibrillators
Study Start Date :	May 2008
Estimated Primary Completion Date :	September 2009
Estimated Study Completion Date :	November 2009

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 1; exercise training	Behavioral: exercise training; walking training at least 3 times a week
Placebo Comparator: 2; control arm: normal behavior, no additional exercise will be advised	Behavioral: exercise training; walking training at least 3 times a week

Outcome Measures

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Primary Outcome Measures :

1. Reduction of arrhythmia burden, heart rate trend, increase in patients activity. [ Time Frame: 6 months ]

Secondary Outcome Measures :

1. Ineffective ICD-interventions, injury risk due to syncope, hospitalization, death. LVEF (echocardiography), VO2max, anaerobic threshold (AT), respiratory compensation point (RCP) and equivalents for O2 and CO2 (ergospirometry) BNP plasma level [ Time Frame: 6 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• both gender at a minimum age of 18 years
• ICD-systems with "Cardiac-Compass" (Medtronic)-diagnostic feature
• ICD system implanted for at least three months
• congestive heart failure, NYHA II and III
• LVEF ≤ 40 %
• compensated state, optimized and stable pharmacological therapy at least for the last three months
• load capacity of at least 50 watt at baseline.

Exclusion Criteria:

• unable or unwilling to give informed consent
• acute coronary syndrome during the past thirty days
• hemodynamically relevant valvular defect
• instable arterial hypertension
• severe COPD
• reduced work load capacity caused by instable angina pectoris, peripheral vascular, neurological or orthopaedic concomitant disease
• hypertrophic obstructive cardiomyopathy (HOCM)
• pulmonary-arterial hypertension (PAP systolic ≥ 60 mmHg).

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Slawomir Weretka, MD	+49 7071 29 83196	weretka@hotmail.com
Contact: Jurgen Schreieck, MD	+49 7071 2982711 ext 8781	juergen.schreieck@med.uni-tuebingen.de

Locations

Germany
University Clinic, Dept. of Cardiology	Recruiting
Tübingen, Baden-Württemberg, Germany, 72076
Contact: Slawomir Weretka, MD +49 7071 29 83196 weretka@hotmail.com
Contact: Jürgen Schreieck, MD +49 7071 29 82711 ext 8781 juergen.schreieck@med.uni-tuebingen.de
Principal Investigator: Slawomir Weretka, MD
Sub-Investigator: Juergen Schreieck, MD
Sub-Investigator: Jochen Hansel, MD
Sub-Investigator: Konstantinos Stellos, MD
Sub-Investigator: Martin Teufel, MD

Sponsors and Collaborators

University Hospital Tuebingen

Investigators

Principal Investigator:	Slawomir Weretka, MD	University Hospital Tuebingen
Study Chair:	Juergen Schreieck, MD	University Hospital Tuebingen

More Information

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Publications:

Lakka TA, Venäläinen JM, Rauramaa R, Salonen R, Tuomilehto J, Salonen JT. Relation of leisure-time physical activity and cardiorespiratory fitness to the risk of acute myocardial infarction. N Engl J Med. 1994 Jun 2;330(22):1549-54.

Schuler G. [Physical activity]. Z Kardiol. 2005;94 Suppl 3:III/11-4. German.

Dürsch M, Schulz O. [Restructuring cardiovascular exercise therapy in Germany with reference to current international guidelines]. Herz. 2003 Aug;28(5):349-58. Review. German.

Schulz O, Dürsch M. [From bench to bicycle. Risk assessment in connection with sports activities and exercise programs in the primary and secondary prevention of cardiovascular diseases]. Herz. 2003 Aug;28(5):359-73. Review. German.

Erbs S, Linke A, Gielen S, Fiehn E, Walther C, Yu J, Adams V, Schuler G, Hambrecht R. Exercise training in patients with severe chronic heart failure: impact on left ventricular performance and cardiac size. A retrospective analysis of the Leipzig Heart Failure Training Trial. Eur J Cardiovasc Prev Rehabil. 2003 Oct;10(5):336-44.

Hambrecht R, Gielen S, Linke A, Fiehn E, Yu J, Walther C, Schoene N, Schuler G. Effects of exercise training on left ventricular function and peripheral resistance in patients with chronic heart failure: A randomized trial. JAMA. 2000 Jun 21;283(23):3095-101.

Belardinelli R, Georgiou D, Cianci G, Purcaro A. Randomized, controlled trial of long-term moderate exercise training in chronic heart failure: effects on functional capacity, quality of life, and clinical outcome. Circulation. 1999 Mar 9;99(9):1173-82.

Kamke W, Dovifat C, Schranz M, Behrens S, Moesenthin J, Völler H. Cardiac rehabilitation in patients with implantable defibrillators. Feasibility and complications. Z Kardiol. 2003 Oct;92(10):869-75.

Vanhees L, Schepers D, Heidbüchel H, Defoor J, Fagard R. Exercise performance and training in patients with implantable cardioverter-defibrillators and coronary heart disease. Am J Cardiol. 2001 Mar 15;87(6):712-5.

Vanhees L, Kornaat M, Defoor J, Aufdemkampe G, Schepers D, Stevens A, Van Exel H, Van Den Beld J, Heidbüchel H, Fagard R. Effect of exercise training in patients with an implantable cardioverter defibrillator. Eur Heart J. 2004 Jul;25(13):1120-6.

Lampert R, Cannom D, Olshansky B. Safety of sports participation in patients with implantable cardioverter defibrillators: a survey of heart rhythm society members. J Cardiovasc Electrophysiol. 2006 Jan;17(1):11-5.

Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MA, Mancini DM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines; American College of Chest Physicians; International Society for Heart and Lung Transplantation; Heart Rhythm Society. ACC/AHA 2005 Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Update the 2001 Guidelines for the Evaluation and Management of Heart Failure): developed in collaboration with the American College of Chest Physicians and the International Society for Heart and Lung Transplantation: endorsed by the Heart Rhythm Society. Circulation. 2005 Sep 20;112(12):e154-235. Epub 2005 Sep 13.

Responsible Party:	Dr. med. Slawomir Weretka, University Hospital Tübingen, Germany
ClinicalTrials.gov Identifier:	NCT00754663 History of Changes
Other Study ID Numbers:	01
First Posted:	September 18, 2008
Last Update Posted:	September 18, 2008
Last Verified:	September 2008

Keywords provided by University Hospital Tuebingen:

exercise; implantable cardioverter-defibrillator; arrhythmia