Validity of SeismoFit VO2max Estimation in Patients With Heart Failure or Ischemic Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Validity of SeismoFit VO2max estimation in HF and IHD patients
研究概览
简要总结
Measurement of cardiorespiratory fitness (VO2max) is considered an important tool in risk prediction of cardiovascular disease and overall patient management. The gold standard method for determining VO2max is a maximal cardiopulmonary exercise test (CPET). This requires time, maximal exercise until voluntary exhaustion and expensive equipment and are therefor not always suitable. A non-exercise VO2max prediction model using seismocardiography (SCG) at rest in combination with demographic data has been proposed as an possible alternative. SCG is a non-invasive three-dimensional measurement technique of precordial vibrations caused by the beating heart and can provide information on cardiac performance. New advances in low-weight three-axis accelerometer, signal processing and feature selection has made this methodology attractive in the recent years. VentriJect Aps has develop a medical device for measuring SCG (SeismoFit) together with an cloud solution for signal processing and prediction of VO2max. The validity of the SeismoFit device has previously been assesses in healthy subjects, but not yet in patients.
The aim of this study is therefore to investigate the validity of the SeismoFit VO2max estimation in patients with heart failure (HF) or ischemic heart disease (IHD).
详细描述
The study is composed of three parts in order to investigate the validity and reliability of the SeimsoFit VO2max estimation.
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A cross-sectional part: 80 patients with HF and 60 patients with IHD are recruited for this part. An interim data analysis is planed after 50% of the patients have been through testing, in order to allow for algorithm adjustment, before the data analysis of the last 50% are performed. This part requires one test day.
-
A longitudinal part: 60 patients with HF and 40 patients with IHD are recruited to perform a follow-up test (from part 1) after being medical customized to the treatment doses. This is typically within 3-4 month, depending on the patient.
This part requires one follow-up test day in addition to the test in part 1.
- A test-retest part: 20 HF and 20 IHD patients are recruited for this part. This part requires one test day within 2-7 days after the last test in part 2.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Fulfilling the guidelines for rehabilitation sat out by the Danish Society of Cardiology.
- •Approved for exercise testing on a cycle ergometer by a specialized doctor in cardiology.
排除标准
- •Absolute contraindications with training
- •Conditions that prevent maximal exercise testing assess by a specialized doctor in cardiology.
结局指标
主要结局
Validity of SeismoFit VO2max estimation in HF and IHD patients
时间窗: 1 day
Assessment of VO2max at rest with SeismoFit and with a gold standard CPET. The validity of the SeismoFit will be based on difference and agreement between the two test methods for both hart failure patients and patients with ischemic heart disease.
次要结局
- Reliability of the SeimoFit VO2max estimation(7 days)
- Detection of change in VO2max using SeismoFit(4-5 month)
研究者
Jørn Wulff Helge
Professor
University of Copenhagen