Table 1.
Randomised controlled trials of IHM-guided HF management compared with standard care
| Trial | First author and year | Design, country | Primary efficacy endpoint | Numbers enrolled | EF | NYHA class | Previous HF event | Follow-up |
| COMPASS-HF | Bourge et al,16 2008 | Single-blind,* multicentre RCT; USA | HF hospitalisation and ED and urgent clinic visit for intravenous therapy (included hypovolaemic events) | 274 | No EF inclusion criterion | III-IV | ≤6 months (or ED visit) | 6 months |
| CHAMPION | Abraham et al,18 2011 | Single-blind,* multicentre RCT; USA | HF hospitalisation | 550 | No EF inclusion criterion | III | ≤12 months | 6 months |
| REDUCE-HF | Adamson et al,10 2011 | Single-blind,* multicentre RCT; USA | HF hospitalisation and ED and urgent clinic visit for intravenous therapy | 400 | No EF inclusion criterion | II-III | ≤12 months | 12 months |
| LAPTOP-HF | Abraham et al,17 2016 | Multicentre RCT (no blinding); USA and New Zealand |
HF hospitalisation and complications from HF therapy | 486 | No EF inclusion criterion | III | ≤12 months (or BNP ≥400 pg/mL or NT-proBNP ≥1500 pg/mL) |
12 months |
| GUIDE-HF | Lindenfeld et al,2 2021 | Single-blind,* multicentre RCT; USA and Canada | All-cause mortality and HF hospitalisation and ED and urgent clinic visit for intravenous therapy | 1000 | No EF inclusion criterion | II – IV | ≤12 months (or BNP ≥250 pg/mL or NT-proBNP ≥1000 pg/mL) |
12 months |
*Patients but not investigators were blinded to haemodynamic data.
BNP, brain natriuretic peptide; CHAMPION, CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in New York Heart Association Class III Heart Failure Patients; COMPASS-HF, Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure; ED, emergency department; EF, ejection fraction; GUIDE-HF, Hemodynamic-Guided Management of Heart Failure; HF, heart failure; IHM, implantable haemodynamic monitor; LAPTOP-HF, Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy; NT-proBNP, N- terminal pro-B-type natriuretic peptide; NYHA, New York Heart Association; RCT, randomised controlled trial; REDUCE-HF, Reducing Events in Patients with Chronic Heart Failure.