Selection of Potential Predictors of Worsening Heart Failure (BioDetectHFIV)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01836510|
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : May 12, 2017
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||922 participants|
|Official Title:||Selection of Potential Predictors of Worsening Heart Failure|
|Actual Study Start Date :||May 2012|
|Actual Primary Completion Date :||February 28, 2017|
|Actual Study Completion Date :||February 28, 2017|
- 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;
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836510
|Cliniche Humanitas Gavazzeni|
|Di Summa Hospital|
|Fondazione Giovanni Paolo II|
|Francesco Ferrari Hospital|
|Ospedale Sant'Anna e San Sebastiano|
|A.O.U. Policlinico Vittorio Emanuele|
|S. Croce Hospital|
|Mater Salutis Hospital|
|Casa di Cura Montevergine|
|Mercogliano (AV), Italy|
|Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte|
|A. O. Monaldi|
|Policlinico Federico II|
|S. Maria della Misericordia|
|S. Maria degli Angeli Hospital|
|Ospedale San Pietro|
|San Filippo Neri|
|A.O.U. San Giovanni di Dio Ruggi d'Aragona|
|Sesto San Giovanni, Italy|
|Santissima Annunziata Hospital|
|S. Maria di Ca' Foncello Hospital|
|A.O.U. Ospedali Riuniti|
|Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology II|
|Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology I|
|Vittoria (RG), Italy|
|Hospital General Universitario de Alicante|
|Hospital Universitario Virgen de la Victoria|
|Study Chair:||Luigi Padeletti, Prof.||A.O.U Careggi, Florence|