SHort Of Pace - Heart Failure (SHOP-HF)

Launched by FUNDACIÓN PARA LA INVESTIGACIÓN DEL HOSPITAL CLÍNICO DE VALENCIA · May 19, 2025

Keywords

ClinConnect Summary

The SHOP-HF clinical trial is studying a new approach to help patients with heart failure, specifically those whose heart is still pumping blood effectively but has other issues like thickened heart walls. In this trial, participants will have a pacemaker implanted, which is a small device that helps control the heart's rhythm. The study will look at how this device affects their heart function over two different periods when it is turned on and off. Each participant will take part in both phases, lasting three months each, and the trial will take place in three centers in Spain.

To be eligible for the trial, participants must be adults aged 18 or older with stable symptoms of heart failure that have been present for at least a month. They should also have certain heart measurements that meet specific guidelines. This includes having a heart function that is still above 50% and experiencing symptoms like fatigue or shortness of breath. Throughout the study, participants will be monitored closely, and the entire follow-up period will last about seven months. It's important to note that the trial is not yet recruiting participants, so interested individuals will need to wait until it begins.

Gender

ALL

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.