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

Stanford University

Status: Active, not recruiting

Conditions: Pulmonary Arterial Hypertension

Treatments: Device: Home-based 6 minute walk test

Study type: Interventional

Funder types: Other

Identifiers

NCT03893500

SU-DynAMITE

IRB-48742 (Other Identifier)

Details and patient eligibility

About

• 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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 2 patient groups

Initiating a new PAH medication

Experimental group

Description:

Participants will start a new PAH medication

Treatment:

Device: Home-based 6 minute walk test

Continuing previous PAH medication regimen

Active Comparator group

Description:

Participants will continue the medication regimen that they were on prior to enrollment

Treatment:

Device: Home-based 6 minute walk test