Table 1.
Schematic representation of study visits and locations.
| Screening (≤14 days from discharge) | Visit 1 (Baseline) | Visit 1.5 (14 ± 3 days) | Visit 2 (42 ± 7 days) | Visit 3 (84 ± 7 days) | Visit 4 (128 ± 14 days) | Urgent visit (as needed) | |
|---|---|---|---|---|---|---|---|
|
| |||||||
| Location | VCU-CMH | VCU-MCV | VCU-CMH or VCU-MCV | VCU-MCV | VCU-MCV | VCU-MCV | VCU-CMH or VCU-MCV |
| Screening | X | ||||||
| Consenting | X | ||||||
| Clinical assessment * | X | X | X | X | X | X | X |
| Biomarkers and safety labs | X | X | X | X | X | X | |
| Investigational therapy dispensing | X | X | X | ||||
| CPX, echo, BIA | X | X | X | X | |||
Abbreviations: BIA = bio-impendance analysis; CPX = cardiopulmonary exercise testing; VCU-CMH = Virginia Commonwealth University Community Memorial Hospital; VCU-MCV = Virginia Commonwealth University Medical College of Cardiology campus.
Clinical assessment includes history and physical, medication reconciliation, and assessment of adverse events.