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, M.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.
(2020) Netherlands Heart Journal, volume 28, issue 1, pp. 16 - 26
(Article)
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;
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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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Keywords: CardioMEMS, e‑Health, Heart failure, Telemonitoring, Therapy, Trial, Cardiology and Cardiovascular Medicine
ISSN: 1568-5888
Publisher: Bohn Stafleu van Loghum
Note: Funding Information: We acknowledge all partners and stakeholders contributing to this project: the Dutch Society of Cardiology (NVVC), patient councils (Harteraad), and National Health Care Institute (Zorginstituut) (ZIN) including ZonMW scientific councils. The MONITOR HF trial is sponsored by the Dutch Ministry of Health and National Health Care Institute (Zorginstituut) for reimbursement and conditional coverage of health-care-related costs and as part of this programme obligatorily sponsored by an independent research grant for clinical study costs from Abbott, which has no role in the trial design, study management, data management analysis or reporting of the findings. Funding Information: The MONITOR HF trial is sponsored by the Dutch Ministry of Health and National Health Care Institute (Zorginstituut) for reimbursement and conditional coverage of health-care-related costs and as part of this programme obligatorily sponsored by an independent research grant for clinical study costs from Abbott, which has no role in the trial design, study management, data management analysis or reporting of the findings. Funding Information: 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. Publisher Copyright: © 2019, The Author(s).
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