REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Quality of life measured using KCCQ-OSS
研究概览
简要总结
HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly. People living with HFpEF also often have coronary artery disease, where the blood vessels that supply the heart are narrowed or blocked.
It is not yet know whether opening these arteries with stents improves symptoms or quality of life with HFpEF. REPRIEVED is a randomised clinical trial that aims to find out if heart stents can improve quality of life for people living with heart failure with preserved ejection fraction (HFpEF) and coronary artery disease.
Researchers will compare two groups of people; those who have a stent procedure to those who have a placebo procedure. The placebo procedure feels the same as a stent procedure but does not include a stent.
350 people with HFpEF and coronary artery disease will be asked to take part. Participants will be monitored over a period of 6 months to see if and how quality of life changes.
Before the procedure, participants will be asked to complete a short health questionnaire, have a blood test, undergo an electrocardiogram (heart tracing) and scans of their heart.
On the day of the procedure, the participant will come to the hospital for an angiogram and will be randomly allocated to have either treatment with a stent or the placebo procedure without a stent. Participants will not know whether they have received heart stents. This helps researchers know that any improvements in their quality of life are not just related to how they feel about the stenting treatment.
Participants will then be contacted by a member of the research team at 3 months and 6 months after their procedure.
At 3 months, participants will complete a short health questionnaire either by phone or during a hospital visit.
At 6 months, participants will attend the hospital to complete a short health questionnaire, have blood tests, a scan of the heart (echocardiogram) and an electrocardiogram (heart tracing) to measure any changes in the heart.
Participants will be told whether they received the stent procedure or the placebo procedure.
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, Outcomes Assessor)
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
- •1. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as:
- •Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and
- •Left ventricular ejection fraction ≥ 50% and
- •NT-pro-BNP > 125 pg/ml in sinus rhythm or > 365 pg/ml in atrial fibrillation and
- •One or more of the following objective signs of left ventricular diastolic dysfunction:
- •i. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) ii. Estimated pulmonary artery systolic pressure > 35mmHg or tricuspid regurgitation velocity > 2.8 m/s on echocardiography iii. Left atrial volume index > 34ml/m2 in patient in sinus rhythm or left atrial volume index > 40ml/m2 in atrial fibrillation iv. Relative left ventricular wall thickness > 0.42 v. Left ventricular mass index ≥ 95 g/m2 in females or ≥ 115 g/m2 in males vi. Mitral E/E' ratio > 9
排除标准
- •Age <18 years
- •People without capacity to provide informed consent
- •PCI contraindicated or not feasible on coronary angiography or screening CTCA
- •Contraindication to clopidogrel/dual antiplatelet therapy
- •Recent acute myocardial infarction or coronary revascularisation (within 90 days)
- •Enrolment in another interventional study which may affect study outcomes
- •Severe chronic obstructive pulmonary disease (GOLD stage ≥3)
- •Haemoglobin <=80 g/L
- •Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)
研究组 & 干预措施
PCI
干预措施: Percutaneous coronary intervention (Procedure)
Placebo PCI
Participants will undergo a placebo stent procedure that involves placement of a catheter but no actual stent. Participants randomised to the placebo procedure will receive matching placebo clopidogrel capsules, to be taken for up to 6 months after the procedure.
干预措施: Placebo procedure (Other)
结局指标
主要结局
Quality of life measured using KCCQ-OSS
时间窗: At 6 months
次要结局
- Health status measured using New York Heart Association (NYHA) functional class(At 6 months)
- All-cause death and hospitalisation for heart failure(At 6 months)
- Efficacy of blinding assessed using the blinding index(At discharge from the procedure)
- Individual components of the KCCQ (including total symptom score and clinical summary score)(At 6 months)
- NT-pro-BNP measured using blood test/assay(At 6 months)
- Difference in left ventricular ejection fraction (LVEF)(At 6 months)
- Difference in diastolic function (mitral E/e')(At 6 months)