Rate-Adaptive Atrial Pacing In Diastolic Heart Failure (RAPID-HF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)
研究概览
简要总结
Determine the impact of restoring normal heart rate response during exercise and daily activity in patients with heart failure and a preserved ejection fraction (HFpEF) and chronotropic incompetence (CI).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age >18 years and able to provide informed consent to enroll in the trial, or consent through a legal guardian or power of attorney.
- •Previous clinical diagnosis of HF with current NYHA Class II-III symptoms
- •At least one of the following: Hospitalization for decompensated HF, Acute treatment for HF with intravenous loop diuretic or hemofiltration, Chronic treatment with a loop diuretic for control of HF symptoms + left atrial enlargement on echocardiography or E/e' ratio (≥14 average, ≥15 septal ) on echocardiography, Resting PCWP >15 mm Hg or LV end-diastolic pressure >18 mmHg at catheterization for dyspnea and/or exercise PCWP/LV end-diastolic pressure >25 mmHg, or Elevated NT-proBNP level (≥300 pg/ml )
- •Left ventricular EF ≥40% within 12 months with clinical stability
- •Stable cardiac medical therapy for ≥30 days
- •Sinus rhythm
- •Chronotropic incompetence on recent (within 6 months) clinical or screening exercise test, defined as heart rate reserve (HRR) <0.80 or <0.62 if on beta blockers
- •Meet both screening criteria on clinically-performed cardiopulmonary exercise testing within 12 months.
排除标准
- •Inability to exercise, or non-cardiac condition that precludes exercise testing
- •Any contraindication to a pacemaker system
- •Non-cardiac condition limiting life expectancy to less than one year
- •Significant left sided structural valve disease (>mild stenosis, >moderate regurgitation)
- •Hypertrophic cardiomyopathy
- •Infiltrative or inflammatory myocardial disease (amyloid, sarcoid)
- •Pericardial disease
- •Non-group 2 pulmonary arterial hypertension
- •Chronic stable exertional angina
- •Acute coronary syndrome or revascularization within 60 days
- •Other clinically important causes of dyspnea
- •Atrial fibrillation
- •PR interval >210 msec
- •Resting heart rate (HR) > 100 bpm
- •A history of reduced ejection fraction (EF<40%)
- •Advanced chronic kidney disease (GFR < 20 ml/min/1.73m2 by modified MDRD equation)
- •Women of child bearing potential without negative pregnancy test and effective contraception
- •Severe anemia (Hemoglobin <10 g/dL)
- •Severe hepatic disease
- •Complex congenital heart disease
- •Listed for cardiac transplantation
- •Other class I indications for pacing
研究组 & 干预措施
Pacing off first, then pacing on
No-pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing on for an additional 4 weeks.
干预措施: Pacemaker system will be implanted but set to Pacing Off. (Device)
Pacing off first, then pacing on
No-pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing on for an additional 4 weeks.
干预措施: Rate adaptive atrial pacing using a dual-chamber pacemaker (Device)
Pacing on first, then pacing off
Pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing off for an additional 4 weeks
干预措施: Rate adaptive atrial pacing using a dual-chamber pacemaker (Device)
Pacing on first, then pacing off
Pacing on for the first for 4 weeks, followed by 4 week washout period, and then cross-over to pacing off for an additional 4 weeks
干预措施: Pacemaker system will be implanted but set to Pacing Off. (Device)
结局指标
主要结局
Change in Oxygen Consumption (VO2) at Ventilatory Anaerobic Threshold (VAT)
时间窗: baseline, after 4 weeks of treatment
Maximal effort cardiopulmonary exercise testing was performed on a treadmill after 4 weeks of pacing-on and after 4 weeks of pacing-off to measure volumes of oxygen consumed (VO2). Change in VO2 at anaerobic threshold (VO2,AT) determined by the V-Slope method as the point of disproportionate rise in VCO2 relative to VO2 as measured in ml/kg/min.
次要结局
- Ventilatory Efficiency (VE/VCO2)(4 weeks)
- Peak Aerobic Capacity (Peak VO2)(4 weeks after pacemaker activation)
- Change in Plasma N-terminal Pro B-type Natriuretic Peptide (NT-proBNP)(baseline, after 4 weeks of treatment)
- Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Overall Summary Score(baseline, after 4 weeks of treatment)
研究者
Barry Borlaug
Principal Investigator
Mayo Clinic