The Characterisation of Vascular Biomarkers Before and After Cardiac Resynchronization Therapy in Patients With Chronic Heart Failure and Their Role in Predicting Response
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Clinical Response
研究概览
简要总结
The purpose of this study is to understand the behaviour of certain blood markers in patients with heart failure who undergo a cardiac device implantation procedure called cardiac resynchronization therapy (CRT). CRT is an effective treatment for heart failure, but up to 30% of people do not respond and have poor outcomes (1,2). Despite extensive investigation, identifying these patients continues to be a challenge. The study intends to describe the changes in these blood markers before and after CRT and to examine any potential clinical value.
The idea behind the study is that these blood markers alter in heart failure and change with CRT implantation. Furthermore the pattern of marker expression before implant and after may predict response and outcome.
详细描述
Study Design A prospective, non-randomised, self-control study of unselected heart failure patients undergoing CRT implantation, all recruited within two years All participants having CRT implantation at University Hospital Coventry and Warwickshire will be screened using the eligibility criteria (outlined below).
Participants will have three assessments within six months (baseline, 6 weeks and 6 months approximately). All visits coincide with routine clinical visits for CRT implantation and interrogation. Assessments at all three time points will include clinical data (including New York Heart Association functional class), quality of life measurements (Minnesota Living with Heart Failure questionnaire), echocardiography data (left ventricular volumetric assessment, ejection fraction), electrocardiograph, functional capacity (6 minute-walk test) and body composition assessment (air displacement). Peripheral blood samples will be taken to examine novel vascular biomarkers and to examine renal function, full blood count, diabetic control (HBA1c - only diabetics) and Brain Natruetic Peptide. Coronary sinus samples will be taken for novel vascular biomarkers in a small proportion of the cohort.
Blood Sampling and Storage
Participants are asked to starve for two hours and rest for one hour before blood sampling. Coronary sinus blood sampling occurs at the time of coronary sinus cannulation before contrast is injected. Blood samples (serum/plasma) are taken in citrate and EDTA tubes. The samples stand at room temperature for a minimum of 30 minutes and undergo centrifugation within an hour. Centrifugation (3500rpm for 10 minutes) occurs at room temperature. Samples are then stored in -80 freezer.
Laboratory Analysis
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Left ventricular ejection fraction ≤35% on echocardiography
- •NYHA Class III/IV symptoms or milder symptoms with:
- •NYHA I (LVEF <35% and QRS>150msec on resting ECG)
- •NYHA II (LVEF <35% with either QRS>150msec or QRS 120-149msec with Left Bundle Branch Block on resting ECG)
- •Optimal medical therapy for heart failure that the patient tolerates (ACEi, Beta-Blocker, Mineralocorticoid) for > 3 months
- •QRS duration ≥120-149msec with LBBB on resting ECG or QRS duration >150msec on resting ECG
- •Patient consent to participation in the study
排除标准
- •Acute heart failure decompensation < 6/52 before implant
- •Significant cognitive impairment
- •Acute coronary syndrome < 6/52 before implant
- •Chronic kidney disease stage V (requiring dialysis)
- •Terminal illness with likely survival < 1 year after implant
- •Post Procedure Exclusions:
- •Failure of procedure (e.g. coronary sinus anatomy)
- •Complication resulting in poor/ none biventricular pacing (e.g. phrenic nerve stimulation, lead displacement/ damage)
结局指标
主要结局
Clinical Response
时间窗: 6 months
Two of three criteria must be fulfilled to be defined as a clinical response: 1. New York Heart Association (NYHA) \> 1 class reduction from baseline 2. Minnesota Living with Heart Failure Questionnaire (MLHFQ) score \< 5 from baseline 3. Six minute walk test (6MWT) increase in baseline distance by 10% Mortality or heart transplantation within 6 months of implant will be defined as a non-response.
次要结局
- Major Adverse Cardiovascular Outcomes(12 months)
- Echocardiographic Response(6 months)
研究者
Dr Christopher McAloon
Cardiology Research Fellow
University Hospitals Coventry and Warwickshire NHS Trust