Randomised controlled trial
Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial
- Randomised controlled trial
- open-label
- 25 centres in the Netherlands
Authors' conclusion
Haemodynamic monitoring substantially improved quality of life and reduced heart failure hospitalisations in patients with moderate-to-severe heart failure treated according to contemporary guidelines.
Study context
- Population
- Chronic HF, NYHA class III, previous HF hospitalisation, irrespective of EF
- Participants
- 348 participants
- Comparison
- Haemodynamic monitoring vs standard care
- CardioMEMS-HFn = 176
- Standard caren = 172reference
- Primary endpoint
- Mean difference in Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score
- Follow-up
- 12 months
Primary result
Change in KCCQ overall summary score
Difference in mean change
7.13
95% CI 1.51–12.75
P = 0.013
By group
CardioMEMS-HF
+7.05
mean change
Standard care
−0.08
mean change
CardioMEMS-HF vs Standard care
difference in mean change 7.13 (95% CI 1.51–12.75); P = 0.013
As reported in the abstract
Further findings
| Outcome | OR (95% CI) | P value | |
|---|---|---|---|
| KCCQ responder analysis: improvement ≥5 points · 12 months | 1.69 (1.01–2.83) | P = 0.046 | |
| KCCQ responder analysis: deterioration ≥5 points · 12 months | 0.45 (0.26–0.77) | P = 0.0035 | |
| 0.20.5125Odds ratio (log scale) |
Safety
| Outcome | CardioMEMS-HF | Standard care |
|---|---|---|
| Freedom from device- or system-related complications and from sensor failure | ||
| Freedom from device/system-related complications | 97.7% | Not reported in the abstract |
| Freedom from sensor failure | 98.8% | Not reported in the abstract |
Original publication
Remote haemodynamic monitoring of pulmonary artery pressures in patients with chronic heart failure (MONITOR-HF): a randomised clinical trial. Lancet. Published 20 May 2023. doi:10.1016/s0140-6736(23)00923-6
Summarised from the published abstract; every number is checked against it