Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Health-Related Quality of Life (HRQoL) status
研究概览
简要总结
This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction ≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (ICD) systems. Patients will be randomly assigned to either personalized accelerated pacing (using the myPACE+ algorithm with mono-fractional exponent) or usual care groups. At baseline and after 3 months of pacing all patients will undergo a CPET, echocardiogram, blood work for NT-proBNP levels and complete the KCCQ-OSS and HCMSQ, questionnaires.
The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pVO2, biomarkers (i.e. NT-proBNP), diastolic parameters and cardiac structure.
详细描述
This will be a two-arm investigator-initiated randomized controlled study of patients with nHCM and LV ejection fraction≥50% and NYHA II-III symptoms, normal intrinsic conduction system and pre-existing suitable dual-chamber implantable cardioverter defibrillators (ICD) systems. Patients will be randomly assigned to either personalized accelerated pacing (using the myPACE+ algorithm with mono-fractional exponent) or usual care groups. At baseline and after 3 months of pacing all patients will undergo a CPET, echocardiogram, blood work for NT-proBNP levels and complete the KCCQ-OSS and HCMSQ, questionnaires.
The investigator team hypothesizes that personalized accelerated pacing will be safe and improve symptoms and heart-failure related quality of life, physical activity, pVO2, biomarkers (i.e. NT-proBNP), diastolic parameters and cardiac structure. An interim data safety analysis will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Researchers collecting pacemaker-detected endpoints cannot be blinded to the rate setting.
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
- •Non obstructive HCM: Left Ventricular Outflow Tract (LVOT) gradient <30mmHg at rest and with provocation
- •Left ventricular ejection fraction (LVEF) ≥50%
- •New York Heart Association (NYHA II-III) symptoms
- •Normal intrinsic conduction system
- •Suitable dual-chamber implantable cardioverter defibrillators (ICD) system
排除标准
- •Pregnancy
- •LVEF <50%
- •LVOT gradient > 30mmHg at rest or with provocation
- •Prolonged PR > 250ms
- •Baseline RV-pacing burden of > 1% more than moderate valvular stenosis or regurgitation
- •Aortic valve replacement in the past one year
- •Significant primary pulmonary disease on home oxygen
- •Uncontrolled hypertension as defined by BP >160/100 mmHg on two measurements ≥15 minutes apart
研究组 & 干预措施
myPACE+
Participants will be programmed to a personalized lower rate setting based on the myPACE+ resting heart rate algorithm will be conducted using the myPACE+ algorithm
干预措施: myPACE+ algorithm (Other)
Usual Care
Standard of care. Participants will retain a standard pacing lower rate setting of 60 beats per minute (bpm).
结局指标
主要结局
Change in Health-Related Quality of Life (HRQoL) status
时间窗: Baseline to 3 months
Change in HRQoL from prior to randomization to the time of 3-month follow-up will be assessed based on patient responses to the 12-item Kansas City Cardiomyopathy Questionnaire (KCCQ-12). The KCCQ-12 is a validated health status measure for patients with heart failure. An overall summary score (OSS) is tabulated based on responses ranging from 0-100, with 0 denoting the worst and 100 the best possible HRQoL status. Change from baseline scores will be summarized by study arm using basic descriptive statistics. A logistic mixed-effect model will be employed to calculate the odds ratio for a ≥ 5 point or more improvement of the KCCQ-OSS, which is considered clinically meaningful.
次要结局
- Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels(Baseline to 3 months)
- Change in Peak Oxygen (pVO2) Uptake and predicted pVO2(Baseline to 3 months)
- Change in pacemaker-detected atrial arrhythmia burden(Baseline to 3 months)
- Change in pacemaker-detected patient activity level(Baseline to 3 months)
- Change in echocardiographic parameters: Left Atrial (LA) Strain(Baseline to 3 months)
- Change in echocardiographic parameters: Left Ventricular (LV) Strain(Baseline to 3 months)
- Change in echocardiographic E/e' ratio(Baseline to 3 months)
- Change in Left Ventricular Myocardial Thickness (LVMT)(Baseline to 3 months)
- Change in Left Atrial (LA) chamber size(Baseline to 3 months)
- Change in Left Ventricular (LV) chamber size(Baseline to 3 months)