Preventing ventricular dysfunction in pacemaker patients without advanced heart failure: rationale and design of the PREVENT-HF study

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 (>or=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.