Skip to main content
. 2020 Mar 3;43(5):430–440. doi: 10.1002/clc.23346

Table 3.

Study schedule

Trial period Screening/Randomization ± Start of Sacubitril/Valsartan/Lifestyle intervention Intervention Discontinuation of Sacubitril/Valsartan/Lifestyle Intervention Follow up Premature treatment discontinuation
Visit number/title Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Discontinuation visit
Schedules days/week/month day 1 Day 14 Day 28 Week 16 (month 4) Week 28 (month 7) At time of permanent treatment discontinuation
Scheduling Window Days/Weeks/Months: ± 2 days ± 2 days ± 2 weeks ± 2 weeks
Administrative procedures
Informed consent x
Informed consent for optional genetic testing (if applicable) (x)
Informed consent for optional Cardiac‐MRI imaging (if applicable) (x)
Inclusion criteria/Exclusion criteria x
Treatment randomization x
Clinical procedures/Assessments
Weight/height x x x x
Vital signs (blood pressure, pulse etc.) x x x x x x
Physical exam x x x x x x
Symptoms x x x x x x
Medical history x
Family history x
Prior and concomitant medication review x x x x x x
Electrocardiogram (12‐lead) x x x x
Transthoracic echocardiogram x x x x
Cardiopulmonary exercise testing x x x x
ECG holter monitoring x x
Blood work x x x x x x
Quality of life questionnaires x x x x
Adverse events monitoring x x x x
Optional genetic testing (if applicable) (x)
Optional Cardiac‐MRI imaging for imaging sub‐study (if applicable) (x) (x)