Short Of Pace: Pacemaker pacing for heart failure with preserved ejection fraction

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

This trial will test whether turning on a pacemaker to raise heart rate helps people with stable HFpEF who have a low resting heart rate and chronotropic incompetence.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia (Academic / other)
• Locations: 1 site (Valencia)
• Trial ID: NCT06992089 on ClinicalTrials.gov

What this trial studies

The trial is a multicenter, prospective, randomized, blinded crossover design in which all participants receive a CE‑marked Boston Scientific pacemaker and are randomized to 3 months with pacing programmed On followed by 3 months Off, or the reverse sequence. Each participant therefore serves as their own control during two 3‑month periods, with blinding of pacing status. Eligible patients have HFpEF with left ventricular hypertrophy, small ventricular volumes, low resting heart rate and documented chronotropic incompetence. The study focuses on symptomatic, stable HFpEF patients and uses device programming changes rather than different implanted devices.

Who should consider this trial

Good fit: Adults with HFpEF (LVEF ≥50%), NYHA II–III/IV, left ventricular hypertrophy with small LV volume, low resting heart rate and documented chronotropic incompetence who can undergo pacemaker implantation and exercise testing.

Not a fit: Patients without chronotropic incompetence, with reduced ejection fraction, large ventricular volumes, inability to perform exercise testing, or who are not candidates for pacemaker implantation are unlikely to benefit.

Why it matters

Potential benefit: If successful, this approach could improve exercise capacity, symptoms, and daily function for patients with HFpEF and chronotropic incompetence.

How similar studies have performed: Rate‑adaptive pacing and chronotropic modulation have shown promise in small studies and observational reports, but randomized blinded crossover evidence specifically in HFpEF is limited, so the approach is relatively novel.

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.

Where this trial is running

Valencia

• Hospital Clínico de la Comunidad Valenciana — Valencia, Spain (Recruiting)

Study contacts

• Principal investigator: Julio Núñez, Doctor — Hospital Clínico Universitario de Valencia
• Study coordinator: Julio Núñez, Doctor

Conditions Heart Failure With Preserved Ejection Fraction