Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Minnesota Living with Heart Failure Questionnaire Score
研究概览
简要总结
Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
All investigators are blinded to patient randomization. To assess subject blinding, participants are asked at 1 month and 12 month follow up if they believed that their pacemaker lower rate was changed.
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
- •Implanted pacemaker with either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing or 3) RV pacing <2% and paced QRS duration <150ms
- •Clinical evidence of heart failure with preserved ejection fraction or diastolic dysfunction, based on:
- •dyspnea with exertion
- •or NYHA Class ≥ II heart failure
- •or pulmonary edema on prior chest imaging or documented on exam
- •or is taking loop diuretics for heart failure
- •or had NTproBNP >400 ng/ml in the last 24 months
- •or a heart failure hospitalization in the last 2 years
- •or has diastolic dysfunction on echo
- •or has left ventricular hypertrophy on echo
- •or has left atrial (LA) dilation (LA volume/BSA index >28ml/m2)
排除标准
- •Left ventricular ejection fraction < 50%
- •Life expectancy < 12 months
- •Symptomatic pulmonary disease on home oxygen
- •Uncontrolled hypertension as defined by blood pressure >160/100 mmHg on two checks ≥15 minutes apart
- •Hypertrophic cardiomyopathy
- •More than moderate valvular disease
- •Aortic valve replacement < 1 year
- •Angina pectoris
- •Creatinine > 2
- •Hemoglobin < 8 g/dL
- •Participation in another clinical trial or registry study
- •Inability to follow up for regularly scheduled pacemaker appointments or to follow up for this study
- •Pregnant patients or patients of childbearing age without reliable contraceptive agent (intra-uterine device, birth control implant, compliance with contraception injections or contraception pills) for the duration of study participation
研究组 & 干预措施
Lower rate set to a higher, personalized backup heart rate (myPACE)
Patients randomized to this group will have their pacemaker lower heart rate setting programmed to a personalized lower rate based on a resting heart rate algorithm.
干预措施: Adjustment of lower rate limit (Device)
Lower rate left at 60 beats-per-minute
Patients randomized to this group will have their pacemaker lower heart rate setting left at or programmed to the conventional pacemaker lower rate setting of 60bpm.
干预措施: Maintenance of lower rate limit (Device)
结局指标
主要结局
Minnesota Living with Heart Failure Questionnaire Score
时间窗: Baseline, 1 month, and 12 months
Change in score from baseline (at enrollment) to 1 month and 12 months after enrollment.
次要结局
- hospitalizations or invasive outpatient intervention for heart failure exacerbation, atrial tachyarrhythmias, cerebrovascular accident, or myocardial infarction(At 12 months)
- NTproBNP(Baseline, 1 month)
- Anti-arrhythmic initiation or up-titration(At 12 months)
- Hospitalization or invasive outpatient intervention for heart failure(At 12 months)
- Loop diuretic initiation or up-titration(At 12 months)
- Pacemaker-detected activity levels(At 12 months)
- Atrial Arrhythmia Burden(At 12 months)
研究者
Margaret Infeld
Physician
University of Vermont