Table 3.
Schedule of Study Visits and Procedures
| Procedure | Screening Day -2 |
Baseline (Day 0) |
Wk 2 (Phone) |
Wk 4 | Wk 6 (Phone) |
Wk 8 | Wk 10 (Phone) |
Wk 12 | Post Wk 2 |
Post Wk 2 (Phone) |
Post Wk 12 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline diet assessment (3-day food record) | X | X | |||||||||
| 24-h urine collection | X | X | X | X | X | X | |||||
| Indirect calorimetry | X | ||||||||||
| History, physical exam, vital signs, anthropometrics | X | X | X | X | X | X | |||||
| Biochemistry, NT-proBNP, and HF biomarkers | X | X | X | X | X | X | |||||
| Review of food diaries | X | X | X | ||||||||
| Adherence assessment | X | X | X | X | X | X | |||||
| Food palatability | X | X | X | ||||||||
| Quality of life (KCCQ) | X | X | |||||||||
| Adverse and clinical events | X | X | X | X | X | X | X | X | X |
KCCQ: Kansas City Cardiomyopathy Questionnaire; NT-proBNP: N-terminal-pro-B-type natriuretic peptide