Selection of Potential Predictors of Worsening Heart Failure
BioDetectHFIV
1 other identifier
observational
922
2 countries
34
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2012
Longer than P75 for all trials
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 19, 2013
CompletedFirst Posted
Study publicly available on registry
April 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2017
CompletedJanuary 18, 2020
May 1, 2017
4.8 years
March 19, 2013
January 14, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
First Hospitalization for worsening Heart Failure (HF)
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;
Participants will be followed for the duration of follow-up, an expected average of 2 years
Secondary Outcomes (1)
A composite of death for worsening heart failure, hospitalizations for worsening HF and acute interventions for worsening HF.
Participants will be followed for the duration of follow-up, an expected average of 2 years
Eligibility Criteria
Population of subjects with an indication for ICD and/or CRT-D implantation according to current guidelines
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
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
Related Publications (1)
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.
PMID: 25036269DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Antonio D'Onofrio, MD
A. O. dei Colli, Vincenzo Monaldi Hospital, Naples
- STUDY CHAIR
Luigi Padeletti, Prof.
IRCSS Multimedica, Milano
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2013
First Posted
April 22, 2013
Study Start
May 1, 2012
Primary Completion
February 28, 2017
Study Completion
February 28, 2017
Last Updated
January 18, 2020
Record last verified: 2017-05