Timeline of trial procedures alongside the assessments that will be carried out at each stage
| Follow-up | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit | Screening | Baseline | Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | Month 15 | Month 18 | Month 21 | Month 24 |
| Additional visits will be arranged to reassess potassium levels if patient's blood results show a potassium level of >5.0 mmol/L | |||||||||||
| Eligibility check | X | X | |||||||||
| Informed consent | X | ||||||||||
| Relevant medical history taken | X | ||||||||||
| Concomitant medication | X | X | X | X | X | X | X | X | X | X | X |
| Standard clinical examination including BP check | X | X | X | X | X | X | X | X | X | X | X |
| Clinical biochemistry | |||||||||||
| Full blood count | X | X | X | X | X | X | X | X | X | X | |
| Renal function, potassium, sodium | X | X | X | X | X | X | X | X | X | X | |
| HbA1c (for diabetics) | X | ||||||||||
| Lipid levels | X | ||||||||||
| ECG | X | X | |||||||||
| Echocardiogram | X | X | |||||||||
| Brain natriuretic peptide test | X | X | |||||||||
| Randomisation | X | ||||||||||
| Dispensing of study drug | X | X | X | X | |||||||
| Cardiopulmonary exercise testing | X | X | |||||||||
| 6 min walk test | X | X | |||||||||
| Quality of life questionnaires | X | X | X | ||||||||
BP, blood pressure; HbA1c, glycated haemoglobin.