Selection of Potential Predictors of Worsening Heart Failure

NCT ID: NCT01836510

Last Updated: 2020-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 922 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2017-02-28

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik SE & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio D'Onofrio, MD

Role: PRINCIPAL_INVESTIGATOR

A. O. dei Colli, Vincenzo Monaldi Hospital, Naples

Luigi Padeletti, Prof.

Role: STUDY_CHAIR

IRCSS Multimedica, Milano

Locations

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

Hospital General Universitario de Alicante

Alicante, , Spain

Hospital Universitario Virgen de la Victoria

Málaga, , Spain

Countries

Italy; Spain

References

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.

Reference Type: DERIVED

PMID: 25036269 (View on PubMed)

Other Identifiers

TA100

Identifier Type: -

Identifier Source: org_study_id