NCT01836510

Selection of Potential Predictors of Worsening Heart Failure

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 922 (actual)
• Sponsor: Biotronik SE & Co. KG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Multicentre study with the objective to correlate heart failure hospitalizations and deaths with Home Monitoring data in ICD/CRT-D recipients, in order to identify the combination of Home Monitoring data with the greatest sensitivity and specificity in predicting Heart Failure events. All data are prospectively collected.

Detailed description

Home Monitoring remotely provides continuous trends of potential HF-related variables with a sampling interval of 24 hours. Although the predictive value of individual variables may be limited, a proper combination of more variables and their 24-hour sampling may allow developing a HM diagnostic algorithm to accurately predict HF worsening within given time windows. The objective of this Study is to select the predictive variables which are most likely to be effectively included in a future algorithm. This is a multicentre, exploratory Study with the objective to prospectively collect follow-up and Home Monitoring data from a population of subjects with indication for ICD and/or CRT-D implantation, to document HF hospitalizations and deaths and to correlate these events with HM data to identify the combination of HM data with the greatest sensitivity and specificity in predicting HF events. Fifty first hospitalizations for worsening HF (adjudicated by an independent board) are necessary to reach the study objective (Event driven study), which were initially assumed to be generated by 650 patients fulfilling inclusion and exclusion criteria. Sample size estimation has been reviewed after an interim analysis.

Conditions

• Heart Failure

Timeline

• Start date: 2012-05-01
• Primary completion: 2017-02-28
• Completion: 2017-02-28
• First posted: 2013-04-22
• Last updated: 2020-01-18

Locations

34 sites across 2 countries: Italy, Spain