The Effect of Biventricular Pacing in Heart Failure With Preserved Left Ventricular Ejection Fraction: A Pilot Mechanistic Analysis
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states.
研究概览
简要总结
A random-order cross-over pilot trial of a CE marked device (pacemaker) outside its current intended purposes.
The study will comprise 10 patients. Recruitment of patients will take place from The University Hospital of Wales (Cardiff & Vale University Health Board [CVUHB]). All patients recruited will have septal flattening during exercise demonstrated using contrast stress (exercise) echocardiography.
All 10 patients will be implanted with a CRT-pacemaker device and will be tested on all three of the following settings on separate visits (with a gap of up to 5 days between visits) in random order:
Routine Medical Therapy Routine Medical Therapy + LVP Routine Medical Therapy + BiVP
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical features consistent with heart failure. All patients will have symptoms of moderate to severe heart failure with New York Heart Association (NHYA) classification III or IV symptoms (for at least 3 months).
- •LV Ejection Fraction less or equal to 50%, with no evidence of significant valvular disease, no hypertrophic or restrictive cardiomyopathy, and no evidence of pericardial constriction.
- •Additionally all patients will have demonstrated evidence of septal flattening during exercise using contrast echocardiography.
- •Adults (over 18 years)
- •Negative test for Covid during surgical pre-assessment, and adherence to prescribed self-isolation before implantation.
- •Two weeks or more following final dose of vaccination against coronavirus.
排除标准
- •Inability to provide informed consent.
- •Enrolment in other clinical studies.
- •BMI more than 35
- •Objective evidence of significant lung disease on formal lung function testing
- •Previous (within three months) or scheduled coronary revascularisation or other cardiac surgery
- •Acute coronary syndrome (within the previous three months)
- •History of atrial fibrillation (AF)
- •Renal insufficiency requiring haemodialysis
- •Life expectancy less than 6 months
- •Prosthetic heart valves
- •Blood coagulation disorders
- •Immunocompromised patients (e.g. AIDS, patients on steroids, cytotoxic drugs, and radiation therapy)
- •Currently pregnant, or intending to conceive.
- •Recent positive Covid test (up to 14 days prior to pre-assessment).
结局指标
主要结局
Change in septal radius of curvature (corrected for LV area) between rest and peak exercise on stress echocardiography across the three pacing states.
时间窗: 12 weeks
次要结局
- Change in rest and exercise E/E' on echocardiography across the three pacing states(12 weeks)
- Change in Systolic and Diastolic mechanical Dyssynchrony Assessment on echocardiography across the three pacing states(12 weeks)
- Change in LV area between rest and exercise across the three pacing states(12 weeks)