Table 4 VENT exclusion criteria

HRCT scan

An HRCT Emphysema Score of 4-4-4 in the right lung or 4-4 in the left lung.

Evidence of large bullae (encompassing >30% of either lung) in a non-target lobe.

Pulmonary function

FEV₁ < 15% predicted value.

DLco < 20% predicted value.

Clinically significant bronchiectasis.

Pulmonary nodule requiring surgery.

History of recurrent respiratory infections (>1 hospitalization in the last year).

Clinically significant (> 4 tablespoons per day) sputum production.

Cardiovascular and exercise

Dysrhythmia that might pose a risk during exercise or training.

Congestive heart failure within 6 mo and LVEF < 45%.

Resting bradycardia (< 50 beats/min), frequent multifocal PVCs, complex ventricular arrhythmia, or sustained SVT.

Myocardial infarction within 6 mo and LVEF < 45%.

Clinical suspicion or proven history of pulmonary hypertension.

History of exercise-related syncope.

Patient is unable to complete 3 minutes of unloaded peddling on cycle ergometer.

Surgical

Prior lung transplant, lung volume reduction surgery, median sternotomy, bullectomy or lobectomy.

General medical

Unplanned weight loss of >10% usual weight in 90 days prior to enrollment or total body weight < 70% of ideal body weight.

Alpha-1 antitrypsin deficiency.

Fever, elevated white cell count, or other evidence of active infection.

Evidence of systemic disease or neoplasia expected to compromise survival during 5-yr period.

Any disease or condition that interferes with completion of initial or follow-up assessments.

Patient is currently enrolled in another clinical trial or has been previously enrolled in the VENT Trial for which protocol required follow up is not complete.