Pulmonary Arterial Hypertension
Conditions
Keywords
Six minute walk test, Six minute walk distance, Heart rate recovery, Mobile health
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.
Interventions
DEVICEHome-based 6 minute walk test
Participants will receive a loaner Apple Watch with the Walk.Talk.Track. (WTT, produced by PHaware) app downloaded. Participants will perform a daily 6MWT at home using the Apple Watch and WTT app. They will undergo a history and physical, blood draw, echocardiogram and in-clinic 6MWT at the baseline and 12-week follow up visit.
Sponsors
Stanford University
PHaware
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| App/Watch Recorded In-clinic Six Minute Walk Distance (6MWD) | 12 weeks | Participants will be asked to walk as far as possible along a corridor for a period of six minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| App/Watch Recorded In-clinic Steps | 12 weeks | App/watch combined recorded and in-clinic recorded step count |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants |
| Distance walked in six minutes (6MWD) at baseline | 506 Meters STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
None listed