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Selection of Potential Predictors of Worsening Heart Failure (BioDetectHFIV)

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ClinicalTrials.gov Identifier: NCT01836510
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Biotronik SE & Co. KG

Brief 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.


Condition or disease
Heart Failure

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.


Study Type : Observational
Actual Enrollment : 922 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure




Primary Outcome Measures :
  1. 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:

    1. It was triggered by increased symptom(s) and sign(s) OR objective evidence of worsening HF (LVEF, ECG, or other instrumental evidences);
    2. It required administration or augmentation of intravenous or oral HF medication;


Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Population of subjects with an indication for ICD and/or CRT-D implantation according to current guidelines
Criteria

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

Information from the National Library of Medicine

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


Locations
Italy
Cliniche Humanitas Gavazzeni
Bergamo, Italy
Spedali Civili
Brescia, Italy
Di Summa Hospital
Brindisi, Italy
Fondazione Giovanni Paolo II
Campobasso, Italy
Francesco Ferrari Hospital
Casarano, Italy
Ospedale Sant'Anna e San Sebastiano
Caserta, Italy
A.O.U. Policlinico Vittorio Emanuele
Catania, Italy
Ospedale Bufalini
Cesena, Italy
Sant'Anna Hospital
Como, Italy
S. Croce Hospital
Cuneo, Italy
San Giuseppe
Empoli, Italy
A.O.U. Careggi
Florence, Italy
Mater Salutis Hospital
Legnago, Italy
Casa di Cura Montevergine
Mercogliano (AV), Italy
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
Messina, Italy
A. O. Monaldi
Naples, Italy
Policlinico Federico II
Napoli, Italy
ARNAS Civico
Palermo, Italy
S. Maria della Misericordia
Perugia, Italy
Ospedale Civile
Piacenza, Italy
S. Maria degli Angeli Hospital
Pordenone, Italy
Ospedale San Pietro
Rome, Italy
Policlinico Casilino
Rome, Italy
San Filippo Neri
Rome, Italy
A.O.U. San Giovanni di Dio Ruggi d'Aragona
Salerno, Italy
IRCCS Multimedica
Sesto San Giovanni, Italy
Santissima Annunziata Hospital
Taranto, Italy
S. Maria di Ca' Foncello Hospital
Treviso, Italy
A.O.U. Ospedali Riuniti
Trieste, Italy
Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology II
Varese, Italy
Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology I
Varese, Italy
Guzzardi Hospital
Vittoria (RG), Italy
Spain
Hospital General Universitario de Alicante
Alicante, Spain
Hospital Universitario Virgen de la Victoria
Malaga, Spain
Sponsors and Collaborators
Biotronik SE & Co. KG
Investigators
Study Chair: Luigi Padeletti, Prof. A.O.U Careggi, Florence

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biotronik SE & Co. KG
ClinicalTrials.gov Identifier: NCT01836510     History of Changes
Other Study ID Numbers: TA100
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017

Keywords provided by Biotronik SE & Co. KG:
Heart Failure
Remote Monitoring
Lung Edema
Patient Monitoring
Prediction

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases