SHort Of Pace - Heart Failure (SHOP-HF)

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®)
  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®).

Первичные конечные точки

• Peak oxygen uptake [Срок оценки: 3 months after the pacemarker stimulation]

Вторичные конечные точки (6)

• Minnesota Living with Heart Failure Questionnaire (MLHFQ) [Срок оценки: From randomization until the end of study in month 7]
• E/E' ratio [Срок оценки: From baseline until the end of study in month 7]
• Left ventricular volume index [Срок оценки: From baseline until the end of study in month 7]
• Left atrial volume index [Срок оценки: From baseline until the end of study in month 7]
• Pro-B-type natriuretic peptide [Срок оценки: From baseline until the end of study in month 7]
• Serum carbohydrate antigen 125 [Срок оценки: From baseline until the end of study in month 7]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Испания · 1 центр

• Hospital Clínico de la Comunidad Valenciana — Valencia

Идентификаторы

NCT: NCT06992089 · SHOP-HF

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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