Heart FailureBioDetectHFIVNCT01836510
Selection of Potential Predictors of Worsening Heart Failure
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 34 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- How many people
- 922 participants
- Where
- 34 sitesin 2 countries
- Study dates
- May 2012to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population of subjects with an indication for ICD and/or CRT-D implantation according to current guidelines
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
34 sites in 2 countries.
34 sites in 2 countries
Italy32 sites
Cliniche Humanitas Gavazzeni
Bergamo
Spedali Civili
Brescia
Di Summa Hospital
Brindisi
Fondazione Giovanni Paolo II
Campobasso
Francesco Ferrari Hospital
Casarano
Ospedale Sant'Anna e San Sebastiano
Caserta
A.O.U. Policlinico Vittorio Emanuele
Catania
Ospedale Bufalini
Cesena
Sant'Anna Hospital
Como
S. Croce Hospital
Cuneo
San Giuseppe
Empoli
A.O.U. Careggi
Florence
Mater Salutis Hospital
Legnago
Casa di Cura Montevergine
Mercogliano (AV)
Azienda Ospedaliera Ospedali Riuniti Papardo Piemonte
Messina
A. O. Monaldi
Naples
Policlinico Federico II
Naples
ARNAS Civico
Palermo
S. Maria della Misericordia
Perugia
Ospedale Civile
Piacenza
S. Maria degli Angeli Hospital
Pordenone
Ospedale San Pietro
Rome
Policlinico Casilino
Rome
San Filippo Neri
Rome
A.O.U. San Giovanni di Dio Ruggi d'Aragona
Salerno
IRCCS Multimedica
Sesto San Giovanni
Santissima Annunziata Hospital
Taranto
S. Maria di Ca' Foncello Hospital
Treviso
A.O.U. Ospedali Riuniti
Trieste
Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology II
Varese
Ospedale di Circolo e Fondazione Macchi, O.U. Cardiology I
Varese
Guzzardi Hospital
Vittoria (RG)
Spain2 sites
Hospital General Universitario de Alicante
Alicante
Hospital Universitario Virgen de la Victoria
Málaga
About this study
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.
Read the 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
- Keywords
- Heart Failure, Remote Monitoring, Lung Edema, Patient Monitoring, Prediction
- Medical subject headings
- Heart Failure, Pulmonary Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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.
Measured: Participants will be followed for the duration of follow-up, an expected average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMay 2012
- Primary completion28 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 922 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik SE & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Antonio D'Onofrio, MD, Principal investigator, A. O. dei Colli, Vincenzo Monaldi Hospital, NaplesLuigi Padeletti, Prof., Study chair, IRCSS Multimedica, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836510
- Sponsor's protocol ID
- TA100
- Acronym
- BioDetectHFIV
- Status last verified
- May 2017
- First submitted
- 19 Mar 2013
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 25036269
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selection of Potential Predictors of Worsening Heart Failure
- ClinicalTrials.gov ID
- NCT01836510
- Acronym / sponsor ID
- BioDetectHFIV / TA100
- Conditions
- Heart Failure
- Keywords
- Heart Failure, Remote Monitoring, Lung Edema, Patient Monitoring, Prediction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- Biotronik SE & Co. KGIndustry (pharma, biotech, devices)
- Study start
- May 2012 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population of subjects with an indication for ICD and/or CRT-D implantation according to current guidelines
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
First Hospitalization for worsening Heart Failure (HF)
Time frame: 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;
1 secondary outcome
A composite of death for worsening heart failure, hospitalizations for worsening HF and acute interventions for worsening HF.
Time frame: Participants will be followed for the duration of follow-up, an expected average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Derived from this study: PubMed 25036269Padeletti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio D'Onofrio, MD principal investigator
A. O. dei Colli, Vincenzo Monaldi Hospital, Naples
Luigi Padeletti, Prof. study chair
IRCSS Multimedica, Milano
34 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Biotronik SE & Co. KG at 34 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in Italy, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Hospitalization for worsening Heart Failure (HF) (time frame: Participants will be followed for the duration of follow-up, an expected average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01836510, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.