Utility of At-home Monitoring of Exercise Capacity by App-based 6-minute Walk Test

Not Recruiting

Trial ID: NCT03893500


- 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.

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

Stanford Investigator(s)

Vinicio de Jesus Perez MD
Vinicio de Jesus Perez MD

Associate Professor of Medicine (Pulmonary and Critical Care Medicine)


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)


device: Home-based 6 minute walk test

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alejandra Elizabeth Lopez