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Remote Monitoring of Chronic Heart Failure in Veneto Region

Information source: Regione Veneto
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Congestive Heart Failure

Intervention: Telemonitoring for patients with Congestive Heart Failure (Procedure)

Phase: N/A

Status: Recruiting

Sponsored by: Regione Veneto

Official(s) and/or principal investigator(s):
Zoran Olivari, DM, Principal Investigator, Affiliation: Azienda Unità Locale Socio Sanitaria n.9 Treviso

Overall contact:
Zoran Olivari, MD, Phone: 0422322767, Email: segcardiotv@ulss.tv.it


The purpose of this study is to evaluate whether telemonitoring of patients with chronic heart failure produces a reduction in the combined end point of all cause mortality and number of hospitalisations, and whether it improves health related quality of life. In addition, the trials evaluate the economic and organisational impact of the telemonitoring service and examine its acceptability by patients and health professionals.

Clinical Details

Official title: RENEWING HEALTH - Large Scale Pilot in Veneto Region: Remote Monitoring of Chronic Heart Failure

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Primary outcome: Combined end point of all cause mortality and number of hospitalisations for heart failure

Secondary outcome:

Cardiovascular and all-cause mortality

Health-Related Quality of Life

Number of hospitalisations (including rehospitalisations) for all causes and for heart failure

Total number of days in hospital

Number of specialist visits

Number of visits at emergency department for heart failure

Anxiety and depression status

Detailed description: The study is designed to evaluate the impact of telemonitoring on the management of CHF compared with outpatient usual care. From a clinical point of view, the trial will allow to investigate how telemonitoring contributes to reduct the combined end point of all cause mortality and re-hospitalizations, as well as the other kinds of access to hospital facilities (bed-days, specialistic and ER visits). The trial will examine whether the CHF patients improve their health-related quality of life and reduct the anxiety about health conditions, thanks to the telemonitoring. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professional perception towards the service.


Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Age ≥ 65 years.

- Discharge from hospital after acute heart failure in the previous 3 months and EF <

40% or EF > 40% plus BNP > 400 (or plus NT-proBNP>1500) during hospitalization Exclusion Criteria:

- Comorbidities prevalent on CHF with life expectation < 12 months.

- Impossibility or inability to use the equipment and help at home not available.

- Myocardial infarction or percutaneous coronary intervention in the last 3 months or


- Coronary artery bypass, valve substitution or correction in the last 6 months.

- Being on waiting list for heart transplantation.

- Being enrolled in other trial

Locations and Contacts

Zoran Olivari, MD, Phone: 0422322767, Email: segcardiotv@ulss.tv.it

Azienda Ospedaliera di Padova - Cardiology Department, Padova 35128, Italy; Recruiting
Sabino Iliceto, MD, Principal Investigator

Ospedale Ca'Foncello - Pulmonology Department, Treviso 31100, Italy; Recruiting
Zoran Olivari, MD, Principal Investigator

Ospedale SS Giovanni e Paolo - Cardiology Department, Venezia 30122, Italy; Recruiting
Michelangelo Penzo, MD, Principal Investigator

Azienda Ospedaliera Universitaria Integrata di Verona - Geriatric Medicine Department, Verona 37124, Italy; Recruiting
Vincenzo Di Francesco, MD, Principal Investigator

Ospedale Immacolata Concezione - Cardiology Department, Piove di Sacco, Padova 35028, Italy; Recruiting
Domenico Marchese, MD, Principal Investigator

Presidio ospedaliero di Conegliano - Department of Cardiology, Conegliano, Treviso 31015, Italy; Recruiting
Carlo Marcon, MD, Principal Investigator

Ospedale di Mirano - Cardiology Department, Mirano, Venezia 30035, Italy; Recruiting
Emanuele Bertaglia, MD, Principal Investigator

Ospedale San Fracastoro - Cardiology Department, San Bonifacio, Verona 37047, Italy; Recruiting
Maurizio Anselmi, MD, Principal Investigator
Claudio Bellamoli, MD, Principal Investigator

Additional Information

The Renewing Health project is partially funded under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Programme by the European Community

Related publications:

Scherr D, Kastner P, Kollmann A, Hallas A, Auer J, Krappinger H, Schuchlenz H, Stark G, Grander W, Jakl G, Schreier G, Fruhwald FM; MOBITEL Investigators. Effect of home-based telemonitoring using mobile phone technology on the outcome of heart failure patients after an episode of acute decompensation: randomized controlled trial. J Med Internet Res. 2009 Aug 17;11(3):e34. doi: 10.2196/jmir.1252.

Clark RA, Inglis SC, McAlister FA, Cleland JG, Stewart S. Telemonitoring or structured telephone support programmes for patients with chronic heart failure: systematic review and meta-analysis. BMJ. 2007 May 5;334(7600):942. Epub 2007 Apr 10. Review.

Inglis SC, Clark RA, McAlister FA, Stewart S, Cleland JG. Which components of heart failure programmes are effective? A systematic review and meta-analysis of the outcomes of structured telephone support or telemonitoring as the primary component of chronic heart failure management in 8323 patients: Abridged Cochrane Review. Eur J Heart Fail. 2011 Sep;13(9):1028-40. doi: 10.1093/eurjhf/hfr039. Epub 2011 Jul 6.

Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16. Erratum in: N Engl J Med. 2013 Nov 7;369(19):1869. N Engl J Med. 2011 Feb 3;364(5):490.

Klersy C, De Silvestri A, Gabutti G, Regoli F, Auricchio A. A meta-analysis of remote monitoring of heart failure patients. J Am Coll Cardiol. 2009 Oct 27;54(18):1683-94. doi: 10.1016/j.jacc.2009.08.017. Review. Erratum in: J Am Coll Cardiol. 2010 May 11;55(19):2185.

Inglis SC, Clark RA, McAlister FA, Ball J, Lewinter C, Cullington D, Stewart S, Cleland JG. Structured telephone support or telemonitoring programmes for patients with chronic heart failure. Cochrane Database Syst Rev. 2010 Aug 4;(8):CD007228. doi: 10.1002/14651858.CD007228.pub2. Review.

Starting date: October 2011
Last updated: January 21, 2014

Page last updated: August 23, 2015

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