Renal Sympathectomy in Heart Failure (the RESPECT-HF Study) - a Study of Renal Denervation for Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 2 期
- 入组人数
- 144
- 试验地点
- 7
- 主要终点
- Compare the changes in left atrial volume index (LAVi) and/or left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (cMRI) between baseline and 6 months
研究概览
简要总结
Investigators will test a new approach to a form of heart failure (HF) with no current treatment proven to reduce death rates or hospitalisations. Over a third of HF cases have preserved ejection fraction (HFPEF) often on a background of high blood pressure (BP). These "stiff" hearts pump strongly but fill inefficiently resulting in poor exercise capacity and high death rates. Treatments that help when heart pumping action is poor are of no benefit in HFPEF. Recently a simple catheter procedure removing excess nerve signals to and from the kidneys ("renal denervation"; RDN) has been able to reduce BP in patients with high BP resistant to multi-drug treatment. Through removing excess nervous drive to the kidneys, heart and circulation this treatment has promise in HF. The investigators will compare effects of RDN and standard medical treatment on heart function, exercise capacity and quality of life in 144 patients with HFPEF
详细描述
Rationale for Research:- Heart failure (HF) is common and lethal. It is the most common diagnosis for medical admissions over 60 years of age, carries a >50% 5 year mortality and accounts for 1-2% of the total national health care budget. HF with preserved ejection fraction (HFPEF) includes over a third of HF cases presenting to New Zealand and Singapore Hospitals and has no treatment proven to reduce mortality or recurrent admissions. Renal denervation (RDN) has proven efficacy in refractory hypertension and its array of effects upon haemodynamic status, neurohumoral activity and renal function make it a rational candidate therapy in HFPEF.
Aims:- The investigators aim to conduct a phase 2 randomized controlled trial of RDN in HFPEF to determine effects upon cardiac structure and function, exercise capacity, and quality of life.
Primary Hypothesis: RDN will reduce left atrial volume index (LAVi) and/or left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (cMRI).
Secondary Hypotheses: RDN will:
- improve exercise capacity and functional status.
- reduce E/e' and echocardiographic grade of diastolic dysfunction.
- reduce circulating biomarkers of cardiac load, interstitial fibrosis and inflammation.
- improve ventricular-vascular function.
- improve Minnesota Living with Heart Failure (MLWHF) scores.
- reduce the composite end-point of death or re-admission with HF.
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
- None
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
- •Patients with HFPEF (based upon ESC diagnostic criteria9)
- •Symptoms and signs of heart failure; NYHA Class II or higher
- •Left ventricular ejection fraction 50% or greater on echocardiography
- •Echocardiographic evidence of left ventricular diastolic dysfunction (echo-Doppler E/e' > 15 )AND/OR plasma NTproBNP > 220pg/ml.
- •Episode of acute decompensation (ADHF)
- •Patients with and without background hypertension may be recruited. In the case of patients with background hypertension (ie history of fulfilling the diagnostic WHO criteria for hypertension: SBP > 140 mmHg and/or DBP > 90 mmHg) those with both controlled (<140/90mmHg by 24 hour ambulatory BP) and inadequately controlled BP (on 3 anti-hypertensive drugs including a diuretic) can be recruited.
排除标准
- •Known secondary cause of hypertension
- •Renal artery stenosis >30% or anatomy otherwise unsuitable for RDN.
- •Heart failure with reduced LV ejection fraction (LVEF < 50%).
- •Estimated glomerular filtration rate (eGFR) of < 30mL/min/1.73m2 (MDRD calculation).
- •Systolic blood pressure < 105mmHg.
- •Implanted pacemaker, prosthetic heart valve or other precluding cMR scanning.
- •Medical condition adversely affecting safety and/or effectiveness of the participant (including peripheral vascular disease, abdominal aortic aneurysm, thrombocytopenia or atrial fibrillation).
- •Pregnant, nursing or planning to be pregnant.
- •Uncontrolled atrial fibrillation, ie with heart rate over 120 bpm
结局指标
主要结局
Compare the changes in left atrial volume index (LAVi) and/or left ventricular mass index (LVMi) on cardiac magnetic resonance imaging (cMRI) between baseline and 6 months
时间窗: baseline, 6 months
次要结局
- Compare the difference in composite end-point of death or hospitalization with Heart Failure between control arm and treatment arm(baseline, 6 months)
- Compare the changes in biomarkers of cardiac load and interstitial fibrosis as assessed by plasma assays of relevant biomarkers(baseline, 6 months)
- Compare the changes of Quality of life as assessed by the Minnesota Living with Heart Failure between baseline and 6 months.(baseline, 6 months)
- Compare the changes in exercise capacity and functional status as assessed by maximal oxygen consumption (VO2max) on cardiopulmonary exercise testing and by 6-minute walk test between baseline and 6 months(baseline, 6 months)
- Compare the changes in chocardiographic grade of diastolic dysfunction as assessed by Tissue Doppler E/e', (a non-invasive estimate of left atrial filling pressure).(baseline, 6 months)
- Compare the changes in ventricular-vascular function as evaluated by echocardiographic measures of arterial elastance, Left Ventricular (LV) end-systolic elastance, LV filling pressure, and LV diastolic stiffness between baseline and 6 months(baseline, 6 months)