Selection of Potential Predictors of Worsening Heart Failure

Completed

• Conditions: Heart Failure

• Registration Number: NCT01836510
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-03-19
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-22
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-05
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 922

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
First Hospitalization for worsening Heart Failure (HF)	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

Name	Time	Method
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

Trial Locations

Locations (34)

Cliniche Humanitas Gavazzeni; 🇮🇹 Bergamo, Italy

Mater Salutis Hospital; 🇮🇹 Legnago, 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

Sant'Anna Hospital; 🇮🇹 Como, Italy

Ospedale Bufalini; 🇮🇹 Cesena, Italy

S. Croce Hospital; 🇮🇹 Cuneo, Italy

San Giuseppe; 🇮🇹 Empoli, Italy

A.O.U. Careggi; 🇮🇹 Florence, Italy

Casa di Cura Montevergine; 🇮🇹 Mercogliano (AV), Italy

A. O. Monaldi; 🇮🇹 Naples, Italy

Policlinico Federico II; 🇮🇹 Napoli, Italy

Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte; 🇮🇹 Messina, Italy

Ospedale Civile; 🇮🇹 Piacenza, Italy

S. Maria degli Angeli Hospital; 🇮🇹 Pordenone, Italy

ARNAS Civico; 🇮🇹 Palermo, Italy

S. Maria della Misericordia; 🇮🇹 Perugia, Italy

Policlinico Casilino; 🇮🇹 Rome, Italy

Ospedale San Pietro; 🇮🇹 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

Guzzardi Hospital; 🇮🇹 Vittoria (RG), Italy

Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology I; 🇮🇹 Varese, Italy

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital Universitario Virgen de la Victoria; 🇪🇸 Malaga, Spain