Heart Arrythmia & Exercise Training (Benefit Heart Center)

Exercise Training in Patients With Cardioverter-Defibrillators (BETA)

Objective

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

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.

IRB Protocol Number

NCT0075466

Principal Investigator(s)

Michael Dillion, MD

Clinical Trial Categories

• Heart and Blood Diseases

Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

Contact

Mike Clark at 319-221-1667
or mike.clark@benefitheart.org

How to Participate

Inclusion criteria:

• Both genders 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)