High-intensity Interval Training as Treatment Strategy for Heart Failure Patients With Preserved Ejection Fraction: A Prospective, Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Change in peak oxygen uptake (VO2peak) due to training
研究概览
简要总结
This study investigates the effects of a 12-week high-intensity interval training (HIT) on exercise tolerance, functional status and quality of life in patients with chronic heart failure with preserved ejection fraction (HFpEF), in comparison to a control group undergoing a 12-week moderate-intensity continuous training.
详细描述
Heart failure (HF) with preserved ejection fraction (HFpEF) occurs in about 50% of all HF patients. Remodeling and fibrosis stimulated by inflammation appear to be main factors for the progression of HFpEF. The lack of prognostic treatment options in HFpEF urgently calls for new therapeutic approaches. While beneficial effects of exercise training have been demonstrated in HF with reduced ejection fraction, they have not yet been evaluated in HFpEF. Therefore, the aim of this study is to investigate the effects of high-intensity interval training (HIT) in HFpEF patients.
The proposed study will be a prospective, single-blind, randomized controlled trial in a primary care setting including 86 patients with stable HFpEF. Patients will undergo 3 study visits (a screening visit, a baseline visit and a post-intervention visit) including measurements of disease-specific biomarkers (using blood samples), cardiac and arterial vessel structure and function (using electrocardiogram, echocardiography, pulse wave velocity, flow-mediated dilation, retinal vessel analysis, cold pressure test), exercise tolerance (using spiroergometry), muscle function (using near-infrared spectroscopy, muscle strength tests), habitual physical activity (using accelerometry) and QoL. After the baseline visit, patients will be randomized to either the intervention or control group. The intervention group (n=43) will attend a supervised 12-week HIT on a bicycle ergometer, while the control group (n=43) will attend a supervised 12-week moderate-intensity continuous training (MCT). After 12 weeks, the study measurements will be repeated in all patients (intervention and control group) in order to monitor the effects of the intervention (post-intervention visit). At 6 months, 1, 2 and 3 years after the last study visit, telephone interviews will be performed to assess medical outcomes and QoL.
Outlook: This study is expected to add important knowledge about the potential utility of a novel treatment strategy in HFpEF patients, which may help to improve both, QoL and functional status. Moreover, the analysed biomarkers might be able to provide further insight into prognosis and pathogenesis of HFpEF.
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
- Single (Outcomes Assessor)
盲法说明
Study personnel involved in the study measurements will be blinded to whether patients are allocated to the intervention or control group. Furthermore, the statistician will be blinded to treatment allocation. To ensure blinding, the study measurements will be performed in different rooms and by different staff than those involved in the training intervention. It is not possible to blind participating patients and investigators performing the randomization and training sessions.
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
- •Informed consent as documented by the patient's signature
- •NYHA functional classes II-III
- •Signs and symptoms of chronic HF:
- •Dyspnea, paroxysmal nocturnal dyspnea
- •Reduced exercise capacity, extended recovery after exercising
- •Peripheral edema (lower leg, ankle)
- •EF (Ejection fraction) >50%
- •Structural or functional changes in echocardiography:
- •LAVI (left atrial volume index) >34 ml/m2 OR
- •LVMI (left ventricular mass index) >115 g/m2 (men), >95 g/m2 (women) OR
- •E/E' (ratio between mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')) >13 AND mean E' septal and lateral wall <9 cm/s
- •NT-proBNP >125 pg/ml
- •At least 4 weeks on stable medical treatment or without signs and symptoms of cardiac decompensation
- •Trainable: Ventilatory threshold >40% of predicted VO2max AND VO2peak >10 ml/kg/min at the screening visit
排除标准
- •Planned cardiac interventions in the following 6 months
- •Unstable angina pectoris
- •Paroxysmal atrial fibrillation
- •Severe uncorrected valvular heart disease
- •Uncontrolled brady- or tachyarrhythmia and hypertonic blood pressure
- •Clinically significant concomitant disease states (e.g. advanced renal failure, hepatic dysfunction, insulin-dependent diabetes, COPD (chronic obstructive pulmonary disease) in grades III-IV, on-going cancer treatment)
- •Significant musculoskeletal disease limiting exercise tolerance
- •Active infection
- •Immunosuppressive medical therapy
- •Earlier hypersensitivity to parenteral iron preparation
- •Anemia and iron deficiency due to active and/or chronic bleeding
- •Blood transfusion within the previous 30 days
- •Vulnerable persons (age <18 years, pregnant and breastfeeding women)
- •Known or suspected non-compliance, drug or alcohol abuse
- •Inability to follow the study procedures due to insufficient language skills, psychological disorders, dementia, etc.
- •Participation in another intervention study
- •Life-expectancy <6 months
结局指标
主要结局
Change in peak oxygen uptake (VO2peak) due to training
时间窗: Baseline and 12 weeks
VO2peak will be measured by spiroergometry at the baseline and post-intervention visit: an incremental symptom-limited exercise test on an electronically operated bicycle ergometer (eBike, General Electric Company, Fairfield, Connecticut, USA) using a fixed ramp protocol (start at 10 watts, increase of 10 watts/minute) will be conducted. The test will be performed in an air-conditioned laboratory in the early afternoon under non-fasting conditions. After a 2-minute warm-up at 10 watts, patients will be instructed to pedal at a constant rate of 60 rpm to exhaustion or until signs of ischemia or serious cardiac arrhythmias appear. The exercise bout will be followed by a cool-down at 25 watts for 10 minutes or until HR is dropping down below 100 beats/minute. VO2peak will be defined as the highest value reached during exercise.
次要结局
- Change QoL: The Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline and 12 weeks)
- Change in NYHA functional class(Baseline and 12 weeks)
- Change in body composition: Waist-to-Hip-Ratio (WHR)(Baseline and 12 weeks)
- Change in disease-specific biomarkers(Baseline and 12 weeks)
- Change in echocardiographic parameters of the left ventricular systolic and diastolic function(Baseline and 12 weeks)
- Change in arteriovenous oxygen difference (Da-vO2)(Baseline and 12 weeks)
- Change in daily physical activity(Baseline and 12 weeks)
- Change in quality of life (QoL): The 36-Item Short Form Health Survey (SF-36)(Baseline and 12 weeks)
- Change in microvascular function: retinal vessel analysis(Baseline and 12 weeks)
- Change in pulse wave velocity (PWV)(Baseline and 12 weeks)
- Change in QoL: The Minnesota Living With Heart Failure Questionnaire (MLWHFQ)(Baseline and 12 weeks)
- Change in macrovascular function: flow-mediated dilation (FMD)(Baseline and 12 weeks)
- Change in body composition: Body Mass Index (BMI)(Baseline and 12 weeks)
- Change in macrovascular function: carotid artery reactivity(Baseline and 12 weeks)
- Change in cardiovascular function: cardiac output(Baseline and 12 weeks)
- Change in muscular function: muscle oxygen saturation(Baseline and 12 weeks)
- Change in muscular function: muscle strength(Baseline and 12 weeks)
研究者
Arno Schmidt-Trucksäss
Clinical Director
University of Basel