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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

Brugts, J. J., Veenis, J. F., Radhoe, S. P., Linssen, G. C. M., van Gent, M., Borleffs, C. J. W., van Ramshorst, J., van Pol, P., Tukkie, R., Spee, R. F., Emans, M. E., Kok, W., van Halm, J. A., Handoko, L., Beeres, S. L. M. A., Post, M. C., Boersma, E., Lenzen, M. J., Manintveld, C., Koffijberg, H., van Baal, P., Versteegh, M., Smilde, T. D., van Heerebeek, L., Rienstra, M., Mosterd, A., Delnoy, P. P. H., Asselbergs, F. W., Brunner-La Rocca, H. P. & de Boer, R. A., Jan-2020, In : Netherlands Heart Journal. 28, 1, p. 16-26 11 p.

Research output: Contribution to journal › Article › Academic › peer-review

APA

Brugts, J. J., Veenis, J. F., Radhoe, S. P., Linssen, G. C. M., van Gent, M., Borleffs, C. J. W., van Ramshorst, J., van Pol, P., Tukkie, R., Spee, R. F., Emans, M. E., Kok, W., van Halm, J. A., Handoko, L., Beeres, S. L. M. A., Post, M. C., Boersma, E., Lenzen, M. J., Manintveld, C., ... de Boer, R. A. (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. Netherlands Heart Journal, 28(1), 16-26. https://doi.org/10.1007/s12471-019-01341-9

Author

Brugts, J. J. ; Veenis, J. F. ; Radhoe, S. P. ; Linssen, G. C. M. ; van Gent, M. ; Borleffs, C. J. W. ; van Ramshorst, J. ; van Pol, P. ; Tukkie, R. ; Spee, R. F. ; Emans, M. E. ; Kok, W. ; van Halm, Jens A. ; Handoko, L. ; Beeres, S. L. M. A. ; Post, M. C. ; Boersma, E. ; Lenzen, M. J. ; Manintveld, C. ; Koffijberg, H. ; van Baal, P. ; Versteegh, M. ; Smilde, T. D. ; van Heerebeek, L. ; Rienstra, M. ; Mosterd, A. ; Delnoy, P. P. H. ; Asselbergs, F. W. ; Brunner-La Rocca, H. P. ; de Boer, R. A. / 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. In: Netherlands Heart Journal. 2020 ; Vol. 28, No. 1. pp. 16-26.

Harvard

Brugts, JJ, Veenis, JF, Radhoe, SP, Linssen, GCM, van Gent, M, Borleffs, CJW, van Ramshorst, J, van Pol, P, Tukkie, R, Spee, RF, Emans, ME, Kok, W, van Halm, JA, Handoko, L, Beeres, SLMA, Post, MC, Boersma, E, Lenzen, MJ, Manintveld, C, Koffijberg, H, van Baal, P, Versteegh, M, Smilde, TD, van Heerebeek, L, Rienstra, M, Mosterd, A, Delnoy, PPH, Asselbergs, FW, Brunner-La Rocca, HP & de Boer, RA 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', Netherlands Heart Journal, vol. 28, no. 1, pp. 16-26. https://doi.org/10.1007/s12471-019-01341-9

Standard

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. / Brugts, J. J.; Veenis, J. F.; Radhoe, S. P.; Linssen, G. C. M.; van Gent, M.; Borleffs, C. J. W.; van Ramshorst, J.; van Pol, P.; Tukkie, R.; Spee, R. F.; Emans, M. E.; Kok, W.; van Halm, Jens A.; Handoko, L.; Beeres, S. L. M. A.; Post, M. C.; Boersma, E.; Lenzen, M. J.; Manintveld, C.; Koffijberg, H.; van Baal, P.; Versteegh, M.; Smilde, T. D.; van Heerebeek, L.; Rienstra, M.; Mosterd, A.; Delnoy, P. P. H.; Asselbergs, F. W.; Brunner-La Rocca, H. P.; de Boer, R. A.

In: Netherlands Heart Journal, Vol. 28, No. 1, 01.2020, p. 16-26.

Research output: Contribution to journal › Article › Academic › peer-review

Vancouver

Brugts JJ, Veenis JF, Radhoe SP, Linssen GCM, van Gent M, Borleffs CJW et al. 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. Netherlands Heart Journal. 2020 Jan;28(1):16-26. https://doi.org/10.1007/s12471-019-01341-9

BibTeX

@article{092477ef79ec4cb184e8312bd5659619,
title = "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, e-Health, Heart failure, Telemonitoring, Therapy, Trial, PULMONARY-ARTERY PRESSURE, DISEASE MANAGEMENT, COST-EFFECTIVENESS, EJECTION FRACTION, MORTALITY, NETWORK, TIME, TELEMEDICINE, THERAPY, ALERTS",
author = "Brugts, {J. J.} and Veenis, {J. F.} and Radhoe, {S. P.} and Linssen, {G. C. M.} and {van Gent}, M. and Borleffs, {C. J. W.} and {van Ramshorst}, J. and {van Pol}, P. and R. Tukkie and Spee, {R. F.} and Emans, {M. E.} and W. Kok and {van Halm}, {Jens A.} and L. Handoko and Beeres, {S. L. M. A.} and Post, {M. C.} and E. Boersma and Lenzen, {M. J.} and C. Manintveld and H. Koffijberg and {van Baal}, P. and M. Versteegh and Smilde, {T. D.} and {van Heerebeek}, L. and M. Rienstra and A. Mosterd and Delnoy, {P. P. H.} and Asselbergs, {F. W.} and {Brunner-La Rocca}, {H. P.} and {de Boer}, {R. A.}",
year = "2020",
month = jan,
doi = "10.1007/s12471-019-01341-9",
language = "English",
volume = "28",
pages = "16--26",
journal = "Netherlands Heart Hournal",
issn = "1568-5888",
publisher = "Bohn, Stafleu, Van Loghum",
number = "1",

}

RIS

TY - JOUR

T1 - 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

AU - Brugts, J. J.

AU - Veenis, J. F.

AU - Radhoe, S. P.

AU - Linssen, G. C. M.

AU - van Gent, M.

AU - Borleffs, C. J. W.

AU - van Ramshorst, J.

AU - van Pol, P.

AU - Tukkie, R.

AU - Spee, R. F.

AU - Emans, M. E.

AU - Kok, W.

AU - van Halm, Jens A.

AU - Handoko, L.

AU - Beeres, S. L. M. A.

AU - Post, M. C.

AU - Boersma, E.

AU - Lenzen, M. J.

AU - Manintveld, C.

AU - Koffijberg, H.

AU - van Baal, P.

AU - Versteegh, M.

AU - Smilde, T. D.

AU - van Heerebeek, L.

AU - Rienstra, M.

AU - Mosterd, A.

AU - Delnoy, P. P. H.

AU - Asselbergs, F. W.

AU - Brunner-La Rocca, H. P.

AU - de Boer, R. A.

PY - 2020/1

Y1 - 2020/1

N2 - 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.

AB - 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.

KW - CardioMEMS

KW - e-Health

KW - Heart failure

KW - Telemonitoring

KW - Therapy

KW - Trial

KW - PULMONARY-ARTERY PRESSURE

KW - DISEASE MANAGEMENT

KW - COST-EFFECTIVENESS

KW - EJECTION FRACTION

KW - MORTALITY

KW - NETWORK

KW - TIME

KW - TELEMEDICINE

KW - THERAPY

KW - ALERTS

U2 - 10.1007/s12471-019-01341-9

DO - 10.1007/s12471-019-01341-9

M3 - Article

VL - 28

SP - 16

EP - 26

JO - Netherlands Heart Hournal

JF - Netherlands Heart Hournal

SN - 1568-5888

IS - 1

ER -

ID: 137421415

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