Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 77
- 试验地点
- 4
- 主要终点
- Correlation of digital mobility assessments with measured pulmonary arterial pressures
研究概览
简要总结
The goal of this observational study is to validate digital mobility outcomes for monitoring the treatment and disease progression in adult patients with pulmonary hypertension. The main question it aims to answer is:
-Do digital mobility outcomes (measured digital endpoints characterizing walking behavior) correlate with measures of precapillary pulmonary pressure as assessed by right heart catheterization?
Participants will be asked to wear a small sensor on the lower back for one week at a time for a total of 3 times: at diagnosis and follow-up visits at 3-6 months and again at 6-12 months. Follow-up visits are scheduled by the treating clinician. At the end of the study participants can choose to receive feedback on the sensor measurements.
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
- •Pulmonary hypertension confirmed by right heart catheterization
- •Presence of precapillary pulmonary hypertension at time of recruitment, defined as mean pulmonary arterial pressure (MAP) ≥ 20 mmHg, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg and pulmonary vascular resistance (PVR) > 2 Wood units (160 dyn·s·cm-5)
- •After the right heart catheterization another follow-up visit is required in 3, 6, or 12 months
- •Independent walking without assistance and a 6-min walking distance > 100m
- •WHO Functional Class I-III
- •Ability to provide informed consent and to participate in the study procedures
- •Willingness to wear the Axivity AX6 Sensor for 7 days
排除标准
- •Hospitalization for a pulmonological disease within the 30 days prior to study recruitment
- •Neurological or orthopedic disease which limits walking ability
- •Acute pain which limits walking ability
- •Poor vision, which limits walking ability
- •Terminal illness with life expectancy < 1 year
- •Ongoing treatment for malignancy
- •Acute psychosis or other severe psychiatric illness
- •Substance dependence
结局指标
主要结局
Correlation of digital mobility assessments with measured pulmonary arterial pressures
时间窗: Baseline assessment at first diagnosis, follow-up assessments after 3-6 months and again after 6-12 months (follow-up time frames are determined by the treating clinician).
Correlation of the digital mobility and walking parameters measured by the Axivity AX6 sensor with the precapillary pulmonary artery pressure during right heart catheterization. As the digital mobility parameters for pulmonary hypertension are still largely unknown, the primary variable will be the average walking speed for walking episodes of \> 30 seconds and compared with the measured pulmonary vascular resistance. The sensor is worn for 1 week at a time for a total of three sets of measurements (determined by scheduled clinical follow-up visits). The goal is to determine the feasibility of digital parameters for risk stratification and measuring disease activity and response to treatment.
次要结局
- Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of walking episodes(Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).)
- Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: duration of walking episodes(Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).)
- Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of steps(Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).)
- Correlation between validated digital mobility outcomes and important prognostic markers of cardiac function(Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).)
- Correlation between digital mobility outcomes and disease progression(Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).)
- Investigation of potential confounders(From enrollment to end of study after the last follow-up visit at 6-12 months.)
研究者
Simon Jäger
Head: Institute of Clinical Pharmacology
Paracelsus Medical University