The
HF Pilot study will be a prospective, multicentre, observational survey of patients presenting to about 200 Cardiology Centers in 12 European countries. Site selection will target a mix of hospitals of different levels of complexity from which patients will be recruited, with a focus on capturing a broad spectrum of cardiology and HF specialty units regularly following outpatients patients with HF and admitting patients with acute, preexisting or new onset HF in order to build-up a network of centers representative of the European reality.
For this specific Pilot phase, patients will be enrolled during 1 day per week of 8 consecutive months and followed up for 1 year. Outpatients visit will be performed at 3, 6 and 12 months after the entry visit.
The
primary objective of this survey is to describe the clinical epidemiology of outpatients and inpatients with HF and the diagnostic/therapeutic processes (including the organisation of HF management programmes) applied in these patients across Europe.
Moreover, the Pilot phase is aimed at validating structure, performance, feasibility of this observational study and quality of the data-set, with the intention of continuing the Survey into a permanent Registry.
All out-patients with HF seen at the clinics and those admitted for acute, preexisting or new onset HF to participating centers during the enrollment period (1 day per week for 8 consecutive months):
- Chronic Heart Failure: All out-patients with chronic HF diagnosed according to the clinical judgment of the responsible cardiologist of the participating centers will be entered in the Survey. There are no specific exclusion criteria, with the exception of age that should be higher than 18 years.
- Acute Heart Failure: Patients admitted to hospital for acute HF for whom an IV therapy (inotropes, vasodilators or diuretics) is needed.
No data will be collected before detailed information is given to the patient and a signed informed consent is obtained.
Twelve countries have been selected (on the basis of previous performance in the
Euro Heart Survey programme and their geographical distribution) to participate at the Pilot phase of the Registry:
- 4 Western European (Austria, France, Germany, the Netherlands)
- 2 Eastern European (Romania, Poland)
- 3 Southern (Greece, Italy, Spain)
- 3 Northern European (Denmark, Norway, Sweden).
The
National Societies of these countries are requested to select a defined number of centres (one center/2 million people, but no more than 25 and no less than 6 per country) in each of their countries to participate in the survey.
The ratio for a country contributing 25 centres should be:
- 5 centres with cardiac surgery,
- 8 with interventional cardiology (PCI/CRT/ICD),
- 12 community centres with no surgery or interventional cardiology.
As far as possible, the centres should respect geographical criteria within each country.
It is anticipated that approximately 2000 to 3000 patients will be enrolled. The survey should commence recruitment of patients in October 2009 and finish in May 2010.
Prof. Aldo Maggioni
Coordinator of the HFA Committee on Surveys and Registries.