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

Clinical endpoint
DOI: 10.1007/s12471-019-01341-9 Publication Date: 2019-12-10T18:03:53Z
ABSTRACT
Assessing haemodynamic congestion based on filling pressures instead of clinical can be a way to further improve quality life (QoL) and outcome by intervening before symptoms or weight gain occur in heart failure (HF) patients. The efficacy remote monitoring pulmonary artery (PA) (CardioMEMS; Abbott Inc., Atlanta, GA, USA) has been demonstrated the USA. Currently, PA sensor is not reimbursed European Union as its benefit when applied addition standard HF care unknown Western countries, including Netherlands.To demonstrate cost-effectiveness contemporary high-quality health system.The current study prospective, multi-centre, randomised trial 340 patients with chronic (New York Heart Association functional class III) CardioMEMS alone. Eligible have at least one hospitalisation for 12 months enrolment will 1:1 ratio. Minimum follow-up 1 year. primary endpoint change QoL measured Kansas City Cardiomyopathy Questionnaire (KCCQ). Secondary endpoints are number hospital admissions changes status assessed EQ-5D-5L questionnaire utilisation formal analysis.The MONITOR evaluate HF. Clinical Trial Registration NTR7672.
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