SHort Of Pace - Heart Failure (SHOP-HF)

NCT ID: NCT06992089

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2026-06-30

Brief 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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Pacing on

Pacemarker stimulation programmed as AAIR / DDDR / VVIR with the basic stimulation frequency and the rate response as follows (pacing on):

• Basic heart rate: derived from the averaged resting heart rates of healthy adults according to height and LVEF.
• Rate response through a combination of minute ventilation and accelerometer: with a response factor of 3 and a medium-low activity threshold.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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®).

Pacing off

VVI 30 bpm

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DEVICE

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®).

Interventions

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®).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación para la Investigación del Hospital Clínico de Valencia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio Núñez, Doctor

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario de Valencia

Locations

Hospital Clínico de la Comunidad Valenciana

Valencia, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Julio Núñez, Doctor

Role: CONTACT

yulnunez@gmail.es

652856689

Vicente Bertomeu, Doctor

Role: CONTACT

vbertog@gmail.com

Facility Contacts

Julio Núñez Villota

Role: primary

Other Identifiers

SHOP-HF

Identifier Type: -

Identifier Source: org_study_id