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NCT Number: NCT06992089

SHort Of Pace - Heart Failure (SHOP-HF)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico de la Comunidad Valenciana

Valencia, 46010, Spain

Location status: Recruiting

Location contact

Julio Núñez Villota

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 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.

Treatment and study plan

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®).

Primary outcomes

  1. Peak oxygen uptake

    Time frame: 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.

Secondary outcomes

  1. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: From randomization until the end of study in month 7

    Absolute changes in quality of live assessed by Minnesota Living with Heart Failure Questionnaire (MLHFQ)

  2. E/E' ratio

    Time frame: From baseline until the end of study in month 7

    Absolute changes in echocardiogram parameters (E/E' ratio)

  3. Left ventricular volume index

    Time frame: From baseline until the end of study in month 7

    Absolute changes in echocardiogram parameters (Left ventricular volume index)

  4. Left atrial volume index

    Time frame: From baseline until the end of study in month 7

    Absolute changes in echocardiogram parameters (Left atrial volume index)

  5. Pro-B-type natriuretic peptide

    Time frame: From baseline until the end of study in month 7

    Absolute and relative changes in prognostic biomarkers (pro-B-type natriuretic peptide)

  6. Serum carbohydrate antigen 125

    Time frame: From baseline until the end of study in month 7

    Absolute and relative changes in prognostic biomarkers (serum carbohydrate antigen 125).

Other outcomes

  1. Acute HF hospitalizations

    Time frame: From baseline until the end of study in month 7

    Total number of episodes of acute HF hospitalizations.

  2. Worsening HF not requiring hospitalization

    Time frame: From baseline until the end of study in month 7

    Total episodes of worsening HF not requiring hospitalization

  3. Mortality

    Time frame: From baseline until the end of study in month 7

    Mortality

Study contacts

Contact information is provided by the study sponsor or research team.

Julio Núñez, Doctor

CONTACT

[email protected]

652856689

Vicente Bertomeu, Doctor

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Fundación para la Investigación del Hospital Clínico de Valencia

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 28, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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