Selection of Potential Predictors of Worsening Heart Failure

Heart Failure Clinical Trial

— BioDetectHFIV  

Official title:

Selection of Potential Predictors of Worsening Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836510
• Other study ID #: TA100
• Status: Completed
• Start date: May 2012
• Est. completion date: February 28, 2017

Study information

• Verified date: May 2017
• Source: Biotronik SE & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 922
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
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 I	Varese
Italy	Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology II	Varese
Italy	Guzzardi Hospital	Vittoria (RG)
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Universitario Virgen de la Victoria	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Biotronik SE & Co. KG

Countries where clinical trial is conducted

Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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: 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;	Participants will be followed for the duration of follow-up, an expected average of 2 years
Secondary	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