Selection of Potential Predictors of Worsening Heart Failure

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.

Completed

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases Lung Diseases Pulmonary Edema Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cliniche Humanitas Gavazzeni, Bergamo, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Left Ventricular Ejection Fraction (LVEF) ≤ 35%
NYHA Class II or III Heart Failure
Men and women 18 years of age or older
Understand the nature of the procedure
Give written informed consent

Exclusion criteria

No indication or contraindication for ICD or CRT-D therapy
Permanent AF
NYHA Class IV Heart Failure
Subjects with irreversible brain damage from preexisting cerebral disease;
Subjects with acutely decompensated heart failure
Expected heart transplantation within next six months or planned cardiac surgery within next 3 months
Have a life expectancy of less than six months
Presence of any disease, other than the subject's cardiac disease associated with a reduced likelihood of survival for the duration of the trial, (e.g. cancer)
Unstable geographical residence (unable to anticipate to be resident in the area of the referring participating centre during the study period) and/or GSM-free residence
Subjects who were not been implanted with ICD or CRT-D devices compatible with HM transmissions
Age <18 years
Pregnancy

Treatment and study plan

Primary outcomes

First Hospitalization for worsening Heart Failure (HF)

Time frame: Participants will be followed for the duration of follow-up, an expected average of 2 years
Hospitalization is defined as a non-elective hospital admission for medical or surgical therapy that results in at least one overnight stay.

Hospitalization for worsening HF is defined as a hospitalization fulfilling the following criteria:
- It was triggered by increased symptom(s) and sign(s) OR objective evidence of worsening HF (LVEF, ECG, or other instrumental evidences);
- It required administration or augmentation of intravenous or oral HF medication;

Secondary outcomes

A composite of death for worsening heart failure, hospitalizations for worsening HF and acute interventions for worsening HF.

Time frame: Participants will be followed for the duration of follow-up, an expected average of 2 years

Sponsors and collaborators

Lead sponsor

Biotronik SE & Co. KG

Industry

Registry information

Acronym: BioDetectHFIV

Important dates

Study start: 2012
Primary completion: 2017
Study completion: 2017
First posted: Apr 22, 2013
Registry last updated: Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed