Table 2.
Reporting of Cardiovascular Exclusion Criteria
| Exclusion criteria | Number of trials reported exclusion, n (%) |
|---|---|
| Any cardiovascular condition | 42 (84) |
| Any CVD | 34 (68) |
| Heart failure | 31 (62) |
| Arrythmia* | 29 (58) |
| Low ejection fraction | 27 (54) |
| Angina | 26 (52) |
| Nonspecific cardiac cause† | 26 (52) |
| Recent myocardial infarction‡ | 25 (50) |
| Hypertension§ | 11 (22) |
| History of hypertension | 10 (20) |
| Structural disease | 8 (16) |
| Ischemic/Coronary heart disease | 8 (16) |
| History of myocardial infarction | 6 (12) |
| QT interval prolongation | 6 (12) |
| Pericardial disorders (effusion or pericarditis) | 5 (10) |
| Stroke (ischemic or hemorrhagic) | 4 (8) |
| Dyspnea | 4 (8) |
| Pro‐arrhythmic medication use | 4 (8) |
| Cardiomyopathy | 3 (6) |
| Thrombosis/thromboembolism | 2 (4) |
| Hypotension | 2 (4) |
| Hypercholesterolemia/hypertriglyceridemia | 2 (4) |
| Aortic aneurysm | 1 (2) |
| Peripheral artery disease | 1 (2) |
| Elevated creatine phosphokinase levels | 1 (2) |
CVD indicates cardiovascular disease.
Includes arrhythmia, atrioventricular block, atrial fibrillation, bradycardia, high‐risk arrhythmia, brugada, torsades, and tachycardia. These arrhythmias were largely labeled as unstable or uncontrolled.
Nonspecific reporting such as “Uncontrolled cardiac/cardiovascular/heart disease, history of heart/cardiac disease or dysfunction, significant or clinically significant cardiac disorders/disease, clinically significant cardiac disease, cardiac/cardiovascular disease precluding study, nonmalignant systemic disease (cardiac), major cardiovascular comorbidity, severe heart disease with life expectancy from disease <2 years, active cardiac disease, other cardiac disease, serious cardiac disease/illness; inclusion of participants with normal cardiopulmonary/cardiac function as assessed by echocardiography, normal/ adequate cardiac function, or functionally preserved heart”. The nonspecificity terms were summarized in the interest of brevity.
Recent myocardial infarction includes myocardial infarctions before specific timeline of study entry, randomization, enrollment, or first dose therapy (8 studies did not specify baseline from which recent myocardial infarctions will be excluded). Different trials listed exclusions at different timelines, 18 trials excluded patients with myocardial infarctions within 6 months, 5 trials excluded patients with myocardial infarctions within 12 months, and 2 trials excluded patients with myocardial infarctions within the past 3 months.
Hypertension as classified as an elevated blood pressure cutoff. Blood pressure cutoffs varied, eg, >140/90 (while on 2 antihypertensive medication) or if systolic blood pressure was >150, >160, >180, <90 mm Hg or if diastolic blood pressures were>90 or >100 mm Hg.