Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial
This study is designed as a multicenter, prospective, controlled, randomized, two-arms, cross-over, two parallel cohorts, efficacy Clinical research with CE-marked medical device . The crossover trial will be performed in a blind fashion, so each participant will be evaluated during both blinded pacing-on and pacing-off phases, each of which will last 3 months. The population includes patients with the diagnosis of stable HFpEF according to criteria of the European Society of Cardiology and New York Heart Association (NYHA) functional class II-III/IV, left ventricular hypertrophy with small ventricular volume, sinus rhythm with low basal heart rate and chronotropic incompetence (CI). All patients will undergo pacemaker implantation, and computer-generated randomization sequence previously designed will be used to allocate participants (in a 1:1 ratio) to receive: (a) programming of the pacemaker with pacing On followed by pacing Off in two periods of 3 months; or (b) programming of the pacemaker with pacing Off followed by pacing On in two periods of 3 months. The study will be conducted in three centers in Spain. Discounting the time due to staggered entry, the total duration of a patient's follow-up will be 7 months.
• Stable symptomatic heart failure (NYHA functional class ≥II) during the last month.
• Diagnosis criteria of HFpEF according to ESC guidelines:
‣ symptoms and signs of HF.
⁃ left ventricular ejection fraction ≥50% by Simpson method.
⁃ proBNP \>125 pg/mL in the last month.
⁃ at least one additional criterion: 1. relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement); and/or 2. Diastolic dysfunction.
• Left ventricular hypertrophy was defined as wall thickness \> 10 mm.
• Small ventricular volume was defined as indexed left ventricular end diastolic volume \< 45 ml/m2.
• Adults ≥18 years old.
• Previous admission for acute heart failure.
• Chronotropic incompetence assessed by CPET, defined as: \[(HRmax - HRrest)\]/\[(220 - age) - (HRrest)\] \< 0.62.
• Resting heart rate \< 65 bpm in sinus rhythm or 70 bmp in atrial fibrillation.