Exercise in Left Ventricular Dysfunction and Chronic Heart Failure Trial - ELVD-CHF

Aug 31, 2003
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Date Presented:
01/01/1997
Date Published:
01/01/2003
Date Updated:
08/31/2003
Original Posted Date:
08/31/2003
References

Description:

The goal of the ELVD-CHF trial was to evaluate the effects of long-term exercise training (ET) on left ventricular (LV) volume and function in patients with stable chronic heart failure (CHF).

Hypothesis:

This multicenter randomized trial explored the long-term effects of a moderate ET program on work capacity, LV function, and quality of life in patients with CHF due to severe LV systolic dysfunction.

Study Design

Study Design:

Patients Screened: 100
Patients Enrolled: 90
NYHA Class: II-III
Mean Follow Up: 6 months
Mean Patient Age: mean age 60 years
Mean Ejection Fraction: Mean baseline EF 25%

Patient Populations:

Heart failure secondary to idiopathic dilated cardiomyopathy, ischemic heart disease, or valvular disease; echocardiographic EF ≤35%; clinical stability for at least three months under optimized therapy; New York Heart Association functional class II-III; peak oxygen uptake <20 ml/kg/min at ergospirometry; and echocardiographic images of adequate quality for quantitative analysis

Exclusions:

Systemic disease limiting exercise, hypertrophic cardiomyopathy, valvular disease requiring surgery, angina pectoris, sustained ventricular arrhythmias, severe hypertension, excess variability at baseline cardiopulmonary exercise test, and inability to participate in a prospective study for any logistic reason

Primary Endpoints:

LV EDV

Drug/Procedures Used:

Patients were randomized to a six-month ET program (n=45) or control group (n=45). At baseline and six-month follow-up, patients underwent functional evaluation, including: 1) physical examination, 2) resting echocardiographic study, 3) symptom-limited cardiopulmonary exercise testing on bicycle ergometry, 4) six-minute walking test, and 5) quality-of-life assessment. The exercise protocol involved supervised continuous sessions of 30-minute bicycle ergometry 3-5 times per week at 60% of the peak oxygen uptake achieved at the initial symptom-limited exercise testing.

Concomitant Medications:

Beta-blockers and angiotensin-converting enzyme (ACE) inhibitors were recommended in both study groups.

Principal Findings:

After six months, LV volumes diminished in patients randomized to ET (end-diastolic volume [EDV], from 142 to 135 ml/m2, p<0.006; end-systolic volume [ESV], from 107 to 97 ml/m2, p<0.05), but increased in the control arm (EDV, from 147 to 156 ml/m2, p<0.01; ESV, from 110 to 118 ml/m2, p<0.01).

Likewise, ejection fraction (EF) improved in the ET arm by 16% (p<0.001), but did not change in the control arm (p=NS). Improvements were also seen in the ET arm in work capacity (from 75 W to 93 W, p<0.001), peak O2 (from 13.8 to 16.2 ml/kg/min, p<0.006), walking distance (from 385 m to 461 m, p<0.001), and quality of life (p<0.01), but not in the control arm (p=NS). There were no changes in either arm in peak exercise with respect to heart rate, systolic blood pressure, and rate-pressure product at six months.

Interpretation:

Among patients with stable CHF, ET was associated with an improvement in the primary endpoint of LV EDV compared with controls at six months. Prior studies have shown that ET programs have been associated with reduction in symptoms, increases in exercise tolerance, and improvements in quality of life. However, the present study was the first to show the antiremodeling effect of ET in addition to medical therapy.

Despite the benefits observed, the authors note that patients in the trial were relatively young (mean age 60 years) with stable CHF, and it is unknown if similar results would occur in older patients or those with decompensated congestive heart failure.

References:

Giannuzzi P, Temporelli PL, Corra U, Tavazzi L, for the ELVD-CHF Study Group. Antiremodeling effect of long-term exercise testing in patients with stable chronic heart failure: results of the Exercise in Left Ventricular Dysfunction and Chronic Heart Failure (ELVD-CHF) Trial. Circulation 2003;108:554-9.

Presented at the 1997 American Heart Association Annual Scientific Session, Clinical Trials, by Pantaleo Giannuzzi, MD, Maugeri Foundation, Veruno, Italy.

Keywords: Exercise Tolerance, Walking, Myocardial Ischemia, Ergometry, Ventricular Function, Left, Quality of Life, Heart Failure, Stroke Volume, Blood Pressure, Oxygen, Heart Rate, Cardiomyopathy, Dilated


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