A randomised comparison of the effect of haemodynamic monitoring with CardioMEMS in addition to standard care on quality of life and hospitalisations in patients with chronic heart failure : Design and rationale of the MONITOR HF multicentre randomised clinical trial

Abstract

Background: Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening before symptoms or weight gain occur in heart failure (HF) patients. The clinical efficacy of remote monitoring of pulmonary artery (PA) pressures (CardioMEMS; Abbott Inc., Atlanta, GA, USA) has been demonstrated in the USA. Currently, the PA sensor is not reimbursed in the European Union as its benefit when applied in addition to standard HF care is unknown in Western European countries, including the Netherlands.

Aims: To demonstrate the efficacy and cost-effectiveness of haemodynamic PA monitoring in addition to contemporary standard HF care in a high-quality Western European health care system.

Methods: The current study is a prospective, multi-centre, randomised clinical trial in 340 patients with chronic HF (New York Heart Association functional class III) randomised to HF care including remote monitoring with the CardioMEMS PA sensor or standard HF care alone. Eligible patients have at least one hospitalisation for HF in 12 months before enrolment and will be randomised in a 1:1 ratio. Minimum follow-up will be 1 year. The primary endpoint is the change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Secondary endpoints are the number of HF hospital admissions and changes in health status assessed by EQ-5D-5L questionnaire including health care utilisation and formal cost-effectiveness analysis.

Conclusion: The MONITOR HF trial will evaluate the efficacy and cost-effectiveness of haemodynamic monitoring by CardioMEMS in addition to standard HF care in patients with chronic HF. Clinical Trial Registration number NTR7672.

Keywords: CardioMEMS; Heart failure; Telemonitoring; Therapy; Trial; e‑Health.

Conflict of interest statement

J.J. Brugts has received speaker fees from Abbott and Vifor. M. Versteegh is a member of the EuroQoL research foundation. W. Kok: has received speaker fees from Novartis and Roche. S.L.M.A. Beeres is a medical advisor at the National Health Care Institute (Zorginstituut Nederland). L. Handoko has received an educational grant from Novartis (<5kE), as well as speaker’s fees from Novartis, Boehringer-Ingelheimand Vifor Pharma. F.W. Asselbergs is supported by UCL Hospitals NIHR Biomedical Research Centre. The UMCG, which employs R.A. de Boer, has received research grants and/or fees from AstraZeneca, Abbott, Bristol-Myers Squibb, Novartis, Novo Nordisk and Roche. R.A. de Boer is a minority shareholder of scPharmaceuticals and has received personal fees from Abbott, AstraZeneca, MandalMed Inc. and Novartis. J.F. Veenis, S.P. Radhoe, G.C.M. Linssen; M. van Gent, C.J.W. Borleffs, J. van Ramshorst, P. van Pol, R. Tukkie, R.F. Spee, M.E. Emans, V. van Halm, M.C. Post, E. Boersma, M.J. Lenzen, O.C. Manintveld, H. Koffijberg, P. van Baal, T.D. Smilde, L. van Heerebeek, M. Rienstra, A. Mosterd, P.P.H. Delnoy and H.P. Brunner-La Rocca declare that they have no competing interests.

Figures

Fig. 1

Participating centres in the Netherlands

Fig. 2

a The CardioMEMS sensor (with permission of Abbott Inc.). b The CardioMEMS HF system patient unit including antenna (with permission of Abbott Inc.). c Location of the CardioMEMS sensor in the left pulmonary artery (with permission of Abbott Inc.)

Fig. 3

The MONITOR HF trial follow-up scheme. Randomisation at baseline visit