Europace Advance Access published online on April 25, 2007
Europace, doi:10.1093/europace/eum064
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Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: rationale and design of the PREVENT-HF study
1 Hospital Clínico Virgen de la Victoria, Campus Universitario Teatinos, 29010 Málaga, Spain; 2 Mount Sinai Medical Center, 4300 Alton Rd, Miami Beach, FL 33140, USA; 3 Hospital Puerta de Hierro, C/ San Martín de Porres, 4. 28035 Madrid, Spain; 4 Universidad Politécnica de Catalunya, C/ Pau Gargallo, 5, 08028 Barcelona, Spain; 5 Medtronic Ibérica, S.A., C/ María de Portugal, 11, 28050 Madrid, Spain; 6 Hospital Clínic i Provincial de Barcelona, Universidad de Barcelona, Villaroel 170, 08036 Barcelona, Spain; 7 Charité—Universitaetsmedizin Berlin, Campus Virchow-Klinikum, Medizinische Klinik M.S. Kardiologie, Augustenburger Platz 1, D-13353 Berlin, Germany
Aims Right ventricular (RV) pacing has been shown to cause heart failure symptoms in patients with and without previous systolic left ventricular (LV) dysfunction. The aim here was to evaluate the preventive effect of biventricular pacing vs. RV apical pacing in patients with indication for permanent ventricular pacing.
Methods PREVENT-HF is an ongoing multicentre randomized controlled pilot study designed to assess whether biventricular pacing is superior to RV pacing in patients receiving a bradycardia pacemaker for standard indications. Patients with Class I or IIa indication according to ACC/AHA guidelines for cardiac pacing judged likely to require high (
80%) ventricular pacing are randomized to receive either RV or biventricular stimulation. Patients are ineligible if younger than 18 years, have Class III or IV heart failure, or experienced a recent myocardial infarction or cardiac surgery. Echocardiographic parameters of LV function are assessed at baseline, 6 months, and 12 months. The primary endpoint is change in LV end diastolic volume. Secondary outcomes include LV ejection fraction, mortality, morbidity, and mitral regurgitation. In subsets of patients, NT-pro-BNP and oxygen uptake are analysed. Centres in Spain (five), Italy (four), and Germany (seven) will enrol 100 patients.
Conclusion PREVENT-HF will contribute to better define the role of chronic biventricular pacing for advanced atrioventricular block.
Key Words: Heart failure, Cardiac resynchronization, Right ventricular pacing, Biventricular pacing
* Corresponding author. Tel: +30 450653635; fax: +30 450553961. E-mail address: martin.stockburger{at}charite.de
Manuscript submitted 12 December 2007. Accepted after revision 13 March 2007.
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