Clinical Trials

Inclusion Criteria:

• Age ≥ 18 years old.
• Subjects speaking any language will be offered participation.
• Subjects capable of providing informed consent to the study.
• Subjects capable of performing cardiopulmonary exercise testing as per pulmonary and cardiology exercise laboratory protocol

Exclusion Criteria:   

• Subjects unable to provide consent, or subjects who do not agree to discuss the study with their parents/guardians.
• Recent surgical procedures (<3 months) that could be affected by lung function testing, including the following categories: Abdominal surgery, Eye surgery, Thoracic surgery, Ear surgery, Brain surgery, Vascular surgery.
• The presence of previously known respiratory disorders including pulmonary embolism (<6 months), pleural effusion, pneumothorax, hemoptysis.
• Recent myocardial infarction (<1 month), new cardiac arrythmia (<3 months), recent cardiac pacemaker implantation (<3 months).
• Heart failure symptoms, significant shortness of breath, tachycardia, or angina
• The presence of chronic pulmonary diseases that maybe associated with changes in pulmonary function overtime such as asthma, chronic obstructive pulmonary disease, or interstitial lung disease.
• The presence of contraindications for CPET (these will be reviewed at the time of recruitment) including:

1. • Active cardiac conditions:
     • active myocardial ischemia
     • decompensated heart failure
     • exercise-induced syncope
     • uncontrolled/untreated arrhythmias
     • known severe aortic stenosis
     • endocarditis
     • myocarditis
     • pericarditis
     • aortic dissection or suspected dissecting aortic aneurysm
     • untreated left main coronary artery stenosis
     • moderate stenotic valvular disease
     • severe hypertension (systolic blood pressure (SBP) greater than 200 mmHg, or diastolic blood pressure (DBP) greater than 120 mmHg)
     • hypertrophic cardiomyopathy
     • second or third-degree atrioventricular block
     • implanted cardiac defibrillator or pacemaker
     • postural orthostatic tachycardia syndrome.
   • Active pulmonary and pulmonary vascular conditions:
     • untreated pulmonary embolism or deep venous thrombosis
     • chronic obstructive pulmonary disease (COPD) exacerbation or uncontrolled asthma
     • acute pulmonary edema
     • resting oxygen saturation of less than 85%
     • acute respiratory failure
     • severe pulmonary hypertension
   • Known abnormal breathing pattern for exercise (known history of vocal cord dysfunction a hypoventilatory response to exercise

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 06/17/2024. Questions regarding updates should be directed to the study team contact.