Trial Search Results

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

- 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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: PHaware

Stanford Investigator(s):

Intervention(s):

  • Device: Home-based 6 minute walk test

Phase:

N/A

Eligibility


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)

Ages Eligible for Study

18 Years - 70 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Ryan j Anderson, MD
650-725-4000
Not Recruiting