SHort Of Pace - Heart Failure (SHOP-HF)
Recruiting · NCT06992089 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Hospital Clínico de la Comunidad Valenciana - Valencia, Spain