Table III.
Schedule of trial visits and procedures
| Active Run-In* | Follow-Up† | ||||||
|---|---|---|---|---|---|---|---|
| Visit Number | 1 | 2 Titration |
3 Titration to Target Dose |
4 On Target Dose |
5 F/U |
6 F/U |
7 F/U |
| Time Point | Screening/Baseline | 2 weeks (from drug initiation‡) |
4 weeks (from drug initiation‡) |
6 weeks (from drug initiation‡) |
6 Months (Group 1 subjects only) |
1 Year (from drug initiation) |
2 Years (from drug initiation) |
| Physical Exam (* BP only) | X | X* | X* | X | X | X | X |
| Cardiac MRI | X | X | |||||
| Echocardiography | X | X | X | ||||
| Cardiopulmonary Exercise Test | X | X | |||||
| ECG | X | X | X | ||||
| Assess for Adverse Events | X | X | X | X | X | X | X |
| Blood for Safety | X | X | X | X | |||
| Pregnancy testing | X | X | X | ||||
| Blood for DNA Banking | X | ||||||
| Fasting Blood for Biomarkers | X | X | X | ||||
| Quality Of Life/Physical activity Questionnaire | X | X | X | ||||
| Dose Adjustment | X | X | |||||
F/U, Follow up; BP, blood pressure; MRI, magnetic resonance imaging; ECG, electrocardiogram.
*
May be performed locally
†
Quarterly telephone communication will also occur during follow up to assess for adverse events and compliance.
‡
Study drug initiation will occur after eligibility is confirmed.