Clinical trial NCT03893500: Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test
Official title: Utility of Device and App-based Mobile Health Monitoring as a Tool for Evaluation of Clinical Response to Therapies in Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Keywords: Six minute walk test
Six minute walk distance
Heart rate recovery
Mobile health
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: PHaware
First posted: 2019-03-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: * Evaluate for accuracy and reproducibility of data collected via the participant-operated Walk.Talk.Track. (WTT) app combined with Apple Watch during in-clinic, technician proctored 6MWT's.

  * Determine whether the WTT app on the Apple Watch can accurately collect information on distance traveled and heart rate (HR) during in-clinic 6MWT run by American Thoracic Society (ATS) guidelines
  * Determine whether participants can operate the WTT app and Apple Watch effectively to gather accurate data in a monitored and home-based setting
* Prospectively monitor for changes in WTT app recorded 6MWT results following initiation of therapy in a treatment naïve cohort of PAH participants

  * Evaluate whether changes from baseline in 6 minute walk distance (6MWD) and heart rate recovery at one minute (HRR1) as well as other variables that have been associated with disease severity in PAH and left-sided heart disease (resting HR, heart rate variability \[HRV\], chronotropic index \[CI\]) can be identified before the 12-week follow up when comparing the treatment arm and the control arm
  * Evaluate whether changes from baseline in the HRR1, resting HR, HRV and/or CI are more evident in treatment responders when compared to treatment non-responders.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of WHO Group I Pulmonary Arterial Hypertension (PAH) (Idiopathic (I)PAH, Heritable PAH (including Hereditary Hemorrhagic Telangiectasia), Associated (A)PAH (including collagen vascular disorders, drugs+toxins exposure, congenital heart disease, and portopulmonary disease).
* Do not meet exclusion criteria

Exclusion Criteria:

* Pulmonary Hypertension due to left heart disease (PH-LHD, WHO group 2), Pulmonary hypertension due to chronic lung disease (PH-CLD, WHO group 3), Chronic thrombo-embolic pulmonary hypertension (CTEPH, WHO group 4), pulmonary hypertension with unclear and/or multi-factorial mechanisms (WHO goup 5)
* Inability to perform a 6 minute walk test (6MWT)

Primary outcomes:
measure: App/watch recorded and in-clinic recorded six minute walk distance (6MWD)
timeFrame: 12 weeks
measure: Count of participants with an increase of >32 meters in 6MWD from baseline as a measure of time to response to therapy
timeFrame: 12 weeks
measure: Count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline as a measure of time to response to therapy
timeFrame: 12 weeks
Secondary outcomes:
measure: Count of participants with a decrease of >5bpm in resting HR from baseline as a measure of time to response to therapy
timeFrame: 12 weeks
measure: Count of participants with an increase of >5ms in heart rate variability (HRV) from baseline as a measure of time to response to therapy
timeFrame: 12 weeks
measure: Count of participants with an increase of >5% in chronotropic index (CI) from baseline as a measure of time to response to therapy
timeFrame: 12 weeks
measure: Within the treatment arm, count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline when comparing medication responders vs non-responders
timeFrame: 12 weeks
measure: Within the treatment arm, count of participants with a decrease of >5bpm in resting HR from baseline when comparing medication responders vs non-responders
timeFrame: 12 weeks
measure: Within the treatment arm, count of participants with an increase of >5ms in heart rate variability (HRV) from baseline when comparing medication responders vs non-responders
timeFrame: 12 weeks
measure: Within the treatment arm, count of participants with an increase of >5% in chronotropic index (CI) from baseline when comparing medication responders vs non-responders
timeFrame: 12 weeks
measure: Between group difference in 6MWD as a measure of response to the intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
References:
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