Fluid status monitoring with a wireless network to reduce cardiovascular-related hospitalizations and mortality in heart failure: rationale and design of the OptiLink HF Study (Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink)

Johannes Brachmann, Michael Böhm, Karin Rybak, Gunnar Klein, Christian Butter, Hanno Klemm, Rolf Schomburg, Johannes Siebermair, Carsten Israel, Anil-Martin Sinha, Helmut Drexler, OptiLink HF Study Executive Board and Investigators, M Böhm, J Brachmann, K Rybak, G Klein, R Bosch, C Butter, H-P Schultheiss, E Erdmann, Johannes Brachmann, Michael Böhm, Karin Rybak, Gunnar Klein, Christian Butter, Hanno Klemm, Rolf Schomburg, Johannes Siebermair, Carsten Israel, Anil-Martin Sinha, Helmut Drexler, OptiLink HF Study Executive Board and Investigators, M Böhm, J Brachmann, K Rybak, G Klein, R Bosch, C Butter, H-P Schultheiss, E Erdmann

Abstract

Aims: The Optimization of Heart Failure Management using OptiVol Fluid Status Monitoring and CareLink (OptiLink HF) study is designed to investigate whether OptiVol fluid status monitoring with an automatically generated wireless CareAlert notification via the CareLink Network can reduce all-cause death and cardiovascular hospitalizations in an HF population, compared with standard clinical assessment. Methods Patients with newly implanted or replacement cardioverter-defibrillator devices with or without cardiac resynchronization therapy, who have chronic HF in New York Heart Association class II or III and a left ventricular ejection fraction ≤35% will be eligible to participate. Following device implantation, patients are randomized to either OptiVol fluid status monitoring through CareAlert notification or regular care (OptiLink 'on' vs. 'off'). The primary endpoint is a composite of all-cause death or cardiovascular hospitalization. It is estimated that 1000 patients will be required to demonstrate superiority of the intervention group to reduce the primary outcome by 30% with 80% power.

Conclusion: The OptiLink HF study is designed to investigate whether early detection of congestion reduces mortality and cardiovascular hospitalization in patients with chronic HF. The study is expected to close recruitment in September 2012 and to report first results in May 2014.

Trial registration: ClinicalTrials.gov NCT00769457.

Figures

Figure 1
Figure 1
Schedule of follow-up in the access arm (with remote monitoring and follow-up) and in the control arm (with in-office visits only). SAEs, serious adverse events.
Figure 2
Figure 2
Intervention algorithm.

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