Pacemaker Implantation in Patients With Heart Failure With Preserved Ejection Fraction, Chronotropic Incompetence and Small Ventricular Volume. The SHOP-HF Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Peak oxygen uptake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •relevant structural heart disease (left ventricular hypertrophy and/or left atrial enlargement); and/or
- •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/m
- •Adults ≥18 years old.
- •Previous admission for acute heart failure.
- •Chronotropic incompetence assessed by CPET, defined as: [(HRmax - HRrest)]/[(220 - age) - (HRrest)] < 0.
- •Resting heart rate < 65 bpm in sinus rhythm or 70 bmp in atrial fibrillation.
排除标准
- •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.
研究组 & 干预措施
Pacing on
Pacemarker stimulation programmed as AAIR / DDDR / VVIR with the basic stimulation frequency and the rate response as follows (pacing on):
- Basic heart rate: derived from the averaged resting heart rates of healthy adults according to height and LVEF.
- Rate response through a combination of minute ventilation and accelerometer: with a response factor of 3 and a medium-low activity threshold.
干预措施: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®) (Device)
Pacing off
VVI 30 bpm
干预措施: Dual-chamber cardiac pacemaker (Essentio MRI L111 Boston Scientific®), Single-chamber cardiac pacemaker (Essentio MRI L110 Boston Scientific®) (Device)
结局指标
主要结局
Peak oxygen uptake
时间窗: 3 months after the pacemarker stimulation
The primary endpoint of the study is absolute and relative changes in peak oxygen uptake (peakVO2) after three months of pacemaker stimulation.
次要结局
- Pro-B-type natriuretic peptide(From baseline until the end of study in month 7)
- Serum carbohydrate antigen 125(From baseline until the end of study in month 7)
- Minnesota Living with Heart Failure Questionnaire (MLHFQ)(From randomization until the end of study in month 7)
- E/E' ratio(From baseline until the end of study in month 7)
- Left ventricular volume index(From baseline until the end of study in month 7)
- Left atrial volume index(From baseline until the end of study in month 7)