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27-11-2019 | Original Article – Design Study Article | Uitgave 1/2020 Open Access

Netherlands Heart Journal 1/2020

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

Tijdschrift:
Netherlands Heart Journal > Uitgave 1/2020
Auteurs:
J. J. Brugts, 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, W. Kok, V. van Halm, L. Handoko, S. L. M. A. Beeres, M. C. Post, E. Boersma, M. J. Lenzen, O. C. Manintveld, H. Koffijberg, P. van Baal, M. Versteegh, T. D. Smilde, L. van Heerebeek, M. Rienstra, A. Mosterd, P. P. H. Delnoy, F. W. Asselbergs, H. P. Brunner-La Rocca, R. A. de Boer
Belangrijke opmerkingen

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s12471-019-01341-9) contains supplementary material, which is available to authorized users.
J.F. Veenis and S.P. Radhoe shared 2nd authorship and contributed equally
Clinical Trial Registration number NTR7672.

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.

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Netherlands Heart Journal

Het Netherlands Heart Journal wordt uitgegeven in samenwerking met de Nederlandse Vereniging voor Cardiologie en de Nederlandse Hartstichting. Het tijdschrift is Engelstalig en wordt gratis beschikbaa ...

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