How is COGNItive Function Affected by Cardiac Resynchronisation Therapy?
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- Change in cognitive function at 6 months post-implant
研究概览
简要总结
The primary objective of COGNI-CRT is to assess whether Cardiac Resynchronisation Therapy (CRT) can improve cognitive function in patients with systolic HF (LVEF ≤35%), when compared to a control group of patients implanted with an Implantable Cardioverter-Defibrillator (ICD) or a permanent pacemaker (PPM) with systolic HF (LVEF ≤35%).
This clinical investigation is a prospective, single-centre cohort study. Each participant will be followed for 6 months. The study will collect data over 3 years; 2.5 years for enrolment and 6 months until the last participant completes the last 6-month follow-up visit.
N.B: COGNI-CRT does NOT affect the patient's care pathway - the patients who will be selected for participation are those who have already been referred for the device implant. The ONLY difference to the patient's care pathway caused by COGNI-CRT is the addition of a battery of cognitive function tests, which involves asking the patient questions and asking them to complete questionnaire-like cognitive tests.
NTpro-BNP levels, NYHA classification and LVEF will be measured prior to device implantation and at 6-months post-implant to assess the device's impact on the participant's heart failure (and CRT response). N.B: NT-proBNP, NYHA classification and LVEF are all parts of the patient's standard care pathway, COGNI-CRT is just utilising the data collected as part of the investigation.
The main study arm and control group allows COGNI-CRT to assess 3 potential outcomes for patients with severe HF (LVEF <35%):
- Cognitive function is not improved by CRT, ICDs or PPMs
- Cognitive function can be improved by the assurance of rate control offered by CRT, ICDs and PPMs
- Cognitive function can be improved by the assurance of ventricular synchronisation and rate control provided by the additional left ventricular lead in CRT devices.
详细描述
Purpose:
The purpose of this clinical investigation is to assess whether cardiac resynchronisation therapy (CRT) can improve cognitive function in patients with systolic heart failure (Left Ventricular Ejection Fraction (LVEF) ≤35%), when compared to a control group of patients implanted with an implantable cardioverter-defibrillator (ICD) or permanent pacemaker (PPM) with systolic heart failure (LVEF ≤35%).
Design:
This clinical investigation is a prospective, single-centre cohort study. The study will be conducted at the Royal Cornwall Hospital Trust (RCHT) in Cornwall, England. Subjects will be followed for 6 months.
Cognitive performance will be assessed in patients pre- and post-CRT implant (Group A). An ICD and PPM control group (Group B) will also be assessed using the same battery of cognitive function tests to ensure any difference in cognitive function which is identified between pre- and post- CRT implant is due to the CRT therapy, and not due to a placebo effect (which can be especially powerful with implanted devices) or due to a learning effect (i.e. patients tested on the second occasion might improve their scores because they have had more practice).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing implant of a CRT system with an LVEF of ≤35% (main group), or ICD or PPM system with an LVEF of ≤35% (control group)
- •Are 20 - 89 years of age
- •Be able to provide written informed consent prior to investigational related procedure, and be willing and able to comply with the described protocols and follow-up schedules listed in the PIS
- •Be literate to a level in which the cognitive function tests can be completed effectively
- •Mental capacity to provide informed consent and undertake cognitive function tests
- •Geographically stable and able to return for the Post-Implant 6-Month Device Follow-Up Visit
排除标准
- •Are ≤19 years of age (due to specifications outlined in cognitive function test requirements)
- •Are ≥90 years of age (due to specifications outlined in cognitive function test requirements)
- •Are pregnant at time of enrolment
- •Is participating in an investigational drug investigation
- •Be experiencing a condition at the time of data collection which affects mental capacity (lack capacitiy), such as dementia, Alzheimer's, psychosis, schizophrenia (excluding depression and anxiety).
- •Recent Cerebral Vascular Event (CVE) which may have affected cognitive function
- •Heavy substance abuse, drugs or alcohol
结局指标
主要结局
Change in cognitive function at 6 months post-implant
时间窗: 6 months
Measured by the use of a 5-stage cognitive battery test
次要结局
- Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) Test at 6 months(6 months)
- Change in left ventricular ejection fraction (LVEF) at 6 months(6 months)
- Change in New York Heart Association (NYHA) Functional Classification(6 months)