SHort Of Pace - Heart Failure (SHOP-HF)

Recruiting now · Not applicable

Conditions studied: Heart Failure With Preserved Ejection Fraction

In brief

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.

Key facts

Study ID: NCT06992089
Run by: Fundación para la Investigación del Hospital Clínico de Valencia
People needed: 30
Starts: 2025-06-17
Expected to finish: 2026-06-01
Last updated by the study team: 2025-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Hospital Clínico de la Comunidad Valenciana — Valencia, Spain (enrolling)

Full record on ClinicalTrials.gov

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