RecruitingNot ApplicableNCT06992089

SHort Of Pace - Heart Failure (SHOP-HF)

Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Enrollment

30 participants

Start Date

Jun 17, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria12

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 Criteria13

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

Interventions

DEVICEDual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)

Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), with rate-adaptive pacing of the right atrium. There will be an associated right atrial lead (INGEVITY™ MRI Pacing Lead Boston®) and right ventricular lead (INGEVITY™ MRI Pacing Lead Boston®). Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®), with rate-adaptive pacing of the ventricles. There will be a right ventricular lead (INGEVITY™ MRI P Boston®).