Tests a pacemaker in adults with heart failure and a small heart chamber

Trial details

Who runs it

Fundación para la Investigación del Hospital Clínico de Valencia

Trial code

NCT06992089

Record updated

12 December 2025

Original description

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).Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: History of an acute coronary syndrome in the previous 12 months; Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease; Effort angina or signs of ischemia during CPET; Significant primary moderate to severe valvular disease; Heart rate at rest > 75 lpm; Patient with prior history of left ventricular ejection fraction <50%; Active treatment with beta-blockers, digitalis or non dihidropiridine calcium channel blockers; Inability to perform a valid baseline exercise test; RER threshold at <1.05 at the CPET; Any other comorbidity with a life expectancy lower than 1 year; Other pacemaker indication; Pregnant women; Baseline rhythm different from sinus rhythm or atrial fibrillation.

ClinicalTrials.gov NCT06992089