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NCT06992089Recruiting

SHort Of Pace - Heart Failure (SHOP-HF)

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

Source: ClinicalTrials.gov · Last updated 12 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
30 (estimated)
First submitted
9 May 2025
Start date
17 Jun 2025
Primary completion date
Jun 2026
Lead sponsor
Fundación para la Investigación del Hospital Clínico de Valencia
NCT number
NCT06992089

What you commit to

  • Study type: Interventional
  • Planned participants: 30
  • From 17 Jun 2025 to the primary completion date, Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • History of an acute coronary syndrome in the previous 12 months.

Other illness

  • Significant primary pulmonary disease; including pulmonary arterial hypertension, chronic thromboembolic pulmonary disease or chronic obstructive pulmonary disease.
  • Effort angina or signs of ischemia during CPET.
  • Significant primary moderate to severe valvular disease.
  • Heart rate at rest \> 75 lpm.

Lab values

  • Patient with prior history of left ventricular ejection fraction \<50%.
  • Active treatment with beta-blockers, digitalis or non dihidropiridine calcium channel blockers.

Other

  • Inability to perform a valid baseline exercise test.
  • RER threshold at \<1.05 at the CPET.
  • Any other comorbidity with a life expectancy lower than 1 year.
  • Other pacemaker indication.
  • Pregnant women.
  • Baseline rhythm different from sinus rhythm or atrial fibrillation.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Clínico de la Comunidad Valenciana
Coordinator of this site? Confirm its status		ValenciaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.