SHort Of Pace - Heart Failure (SHOP-HF)

NCT06992089 | Recruiting DMC

• 1 other identifier: SHOP-HF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Peak oxygen uptake

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

  3 months after the pacemarker stimulation

Secondary Outcomes (6)

• Minnesota Living with Heart Failure Questionnaire (MLHFQ)

  From randomization until the end of study in month 7

• E/E' ratio

  From baseline until the end of study in month 7

• Left ventricular volume index

  From baseline until the end of study in month 7

• Left atrial volume index

  From baseline until the end of study in month 7

• Pro-B-type natriuretic peptide

  From baseline until the end of study in month 7

Other Outcomes (3)

• Acute HF hospitalizations

  From baseline until the end of study in month 7

• Worsening HF not requiring hospitalization

  From baseline until the end of study in month 7

• Mortality

  From baseline until the end of study in month 7

Study Arms (2)

Pacing on

EXPERIMENTAL

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.

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

Pacing off

PLACEBO COMPARATOR

VVI 30 bpm

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

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

Hospital Clínico de la Comunidad Valenciana

Valencia, 46010, Spain

RECRUITING

Study Officials

• Julio Núñez, Doctor

  Hospital Clínico Universitario de Valencia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Núñez, Doctor

CONTACT

652856689; yulnunez@gmail.es

Vicente Bertomeu, Doctor

CONTACT

vbertog@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 28, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)