SHort Of Pace - Heart Failure (SHOP-HF)

NCT06992089 · tracked via the Priya Life Science Spain tracker

Sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Phase

Not applicable

Started

2025-06-17

Last updated

2025-12-12

Condition(s) studied

Heart Failure With Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

Dual-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®), 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®).

Study 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

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Stable symptomatic heart failure (NYHA functional class ≥II) during the last month. * Diagnosis criteria of HFpEF according to ESC guidelines: 1. symptoms and signs of HF. 2. left ventricular ejection fraction ≥50% by Simpson method. 3. proBNP \>125 pg/mL in the last month. 4. 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 Criteria: * 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.

Primary outcome measure(s)

Peak oxygen uptake — 3 months after the pacemarker stimulation
The primary endpoint of the study is absolute and relative changes in peak oxygen uptake (peakVO2) after three months of pacemaker stimulation.

Trial sites (1)

Facility	City	Region	Status
Hospital Clínico de la Comunidad Valenciana	Valencia	Spain	Recruiting

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Other trials for the same condition

Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06992089 on ClinicalTrials.gov ↗ ← All trials in Spain