Clinical trial NCT01836510: Selection of Potential Predictors of Worsening Heart Failure
Official title: Selection of Potential Predictors of Worsening Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure
Remote Monitoring
Lung Edema
Patient Monitoring
Prediction
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-04-22
Enrollment: 922
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population of subjects with an indication for ICD and/or CRT-D implantation according to current guidelines

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.

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.

Eligibility 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

Primary outcomes:
measure: First Hospitalization for worsening Heart Failure (HF)
timeFrame: Participants will be followed for the duration of follow-up, an expected average of 2 years
Secondary outcomes:
measure: A composite of death for worsening heart failure, hospitalizations for worsening HF and acute interventions for worsening HF.
timeFrame: Participants will be followed for the duration of follow-up, an expected average of 2 years
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Cliniche Humanitas Gavazzeni
city: Brescia
country: Italy
facility: Spedali Civili
city: Brindisi
country: Italy
facility: Di Summa Hospital
city: Campobasso
country: Italy
facility: Fondazione Giovanni Paolo II
city: Casarano
country: Italy
facility: Francesco Ferrari Hospital
city: Caserta
country: Italy
facility: Ospedale Sant'Anna e San Sebastiano
city: Catania
country: Italy
facility: A.O.U. Policlinico Vittorio Emanuele
city: Cesena
country: Italy
facility: Ospedale Bufalini
city: Como
country: Italy
facility: Sant'Anna Hospital
city: Cuneo
country: Italy
facility: S. Croce Hospital
city: Empoli
country: Italy
facility: San Giuseppe
city: Florence
country: Italy
facility: A.O.U. Careggi
city: Legnago
country: Italy
facility: Mater Salutis Hospital
city: Mercogliano (AV)
country: Italy
facility: Casa di Cura Montevergine
city: Messina
country: Italy
facility: Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
city: Naples
country: Italy
facility: A. O. Monaldi
city: Napoli
country: Italy
facility: Policlinico Federico II
city: Palermo
country: Italy
facility: ARNAS Civico
city: Perugia
country: Italy
facility: S. Maria della Misericordia
city: Piacenza
country: Italy
facility: Ospedale Civile
city: Pordenone
country: Italy
facility: S. Maria degli Angeli Hospital
city: Rome
country: Italy
facility: Ospedale San Pietro
city: Rome
country: Italy
facility: Policlinico Casilino
city: Rome
country: Italy
facility: San Filippo Neri
city: Salerno
country: Italy
facility: A.O.U. San Giovanni di Dio Ruggi d'Aragona
city: Sesto San Giovanni
country: Italy
facility: IRCCS Multimedica
city: Taranto
country: Italy
facility: Santissima Annunziata Hospital
city: Treviso
country: Italy
facility: S. Maria di Ca' Foncello Hospital
city: Trieste
country: Italy
facility: A.O.U. Ospedali Riuniti
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology II
city: Varese
country: Italy
facility: Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology I
city: Vittoria (RG)
country: Italy
facility: Guzzardi Hospital
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
Study officials:
affiliation: A. O. dei Colli, Vincenzo Monaldi Hospital, Naples
name: Antonio D'Onofrio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: IRCSS Multimedica, Milano
name: Luigi Padeletti, Prof.
role: STUDY_CHAIR
References:
citation: Padeletti L, Botto GL, Curnis A, De Ruvo E, D'Onofrio A, Gronda E, Ricci RP, Vado A, Zanotto G, Zecchin M, Antoniou X, Gargaro A. Selection of potential predictors of worsening heart failure: rational and design of the SELENE HF study. J Cardiovasc Med (Hagerstown). 2015 Nov;16(11):782-9. doi: 10.2459/JCM.0000000000000171.