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

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. KoffijbergP. 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

*Corresponding author for this work

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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.

Original languageEnglish
Pages (from-to)1-11
Number of pages11
JournalNetherlands heart journal
Early online date10 Dec 2019
DOIs
Publication statusE-pub ahead of print/First online - 10 Dec 2019

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Hospitalization
Randomized Controlled Trials
Heart Failure
Hemodynamics
Quality of Life
Pulmonary Artery
Cost-Benefit Analysis
Patient Acceptance of Health Care
Pressure
European Union
Cardiomyopathies
Netherlands
Health Status
Weight Gain
Patient Care
Clinical Trials
Delivery of Health Care

Keywords

  • CardioMEMS
  • e‑Health
  • Heart failure
  • Telemonitoring
  • Therapy
  • Trial

Cite this

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, V. ; Handoko, L. ; Beeres, S. L.M.A. ; Post, M. C. ; Boersma, E. ; Lenzen, M. J. ; Manintveld, O. 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. 2019 ; pp. 1-11.
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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",
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}, V. and L. Handoko and Beeres, {S. L.M.A.} and Post, {M. C.} and E. Boersma and Lenzen, {M. J.} and Manintveld, {O. C.} 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.}",
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language = "English",
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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, V, Handoko, L, Beeres, SLMA, Post, MC, Boersma, E, Lenzen, MJ, Manintveld, OC, 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 2019, '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, pp. 1-11. https://doi.org/10.1007/s12471-019-01341-9

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, V.; Handoko, L.; Beeres, S. L.M.A.; Post, M. C.; Boersma, E.; Lenzen, M. J.; Manintveld, O. 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, 10.12.2019, p. 1-11.

Research output: Contribution to journalArticleAcademicpeer-review

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

T2 - 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, V.

AU - Handoko, L.

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

AU - Post, M. C.

AU - Boersma, E.

AU - Lenzen, M. J.

AU - Manintveld, O. 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 - 2019/12/10

Y1 - 2019/12/10

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

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U2 - 10.1007/s12471-019-01341-9

DO - 10.1007/s12471-019-01341-9

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AN - SCOPUS:85075991355

SP - 1

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JO - Netherlands heart journal

JF - Netherlands heart journal

SN - 1568-5888

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