Sudden Cardiac Death Clinical Trial
Official title:
Effects of Exercise Training on Non-invasive Cardiac Measures in Patients Undergoing Long-term Hemodialysis: A Randomized Controlled Trial
Background: The impact of the known non-invasive cardiac indices for identification of
hemodialysis (HD) patients at high-risk for sudden cardiac death (SCD) has not been
evaluated.
Patients: Fifty-nine HD patients were randomized into 2 groups. Thirty of them (group A-aged
54.6±8.9 years) participated in a supervised training program with stationary bicycles during
their HD sessions (3/weekly) for 10 months, while the rest (group B-aged 53.2±6.1 years)
remained untrained and were used as controls.
Study hypothesis: Exercise training will affect most of the non-invasive cardiac markers of
SCD and the total score positively.
Method: At entry, as well as at the end of the study all subjects underwent a cardiopulmonary
exercise testing (estimation of aerobic capacity-VO2peak), an echocardiographic study (LV
ejection fraction -LVEF evaluation), an ambulatory 24-hour Holter monitoring for cardiac
autonomic nervous system activity evaluation by time- and frequency- domain heart rate
variability (HRV) calculation (measurement of SDNN, mean RR and low to high frequency
ratio-LF/HF), a signal-averaged ECG (late potentials-LP documentation) and a submaximal
exercise test for microvolt-T-wave alternans (TWA) detection.
The identification of patients on hemodialysis (HD) at increased cardiac risk with powerful
screening tests and the reduction of factors, which increase the probability of malignant
arrhythmias are important for primary prevention of sudden cardiac death (SCD).
Study Design: randomized and controlled clinical trial. Setting & Participants: Fifty-nine HD
patients were randomized into exercise training group (group A-30 patients) and controls
(group B-29 patients).
Intervention: Group A participated in a 10-month supervised exercise training program during
the HD sessions (3/weekly).
Outcomes: The effects of exercise on the score of the non-invasive cardiac markers for SCD
risk stratification and on the occurrence of each variable separately. Statistical analysis
included a two-group comparison of change scores and an analysis of covariance adjusting for
baseline.
Measurements: At entry and the end of the study, in all participants aerobic capacity
(VO2peak) and left ventricular ejection fraction (LVEF) were estimated, late potentials and
T-wave alternans were detected and heart rate variability was calculated. Specifically, from
the 24-h Holter monitoring the standard deviation of all the normal R-R intervals (SDNN), the
mean R-R intervals (mean RR), the low (LF) and high (HF) frequency components of the
autoregressive power spectrum of the NN intervals and their ratio (LF/HF) were recorded.
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