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At-home Monitoring of Exercise Capacity for Pulmonary Hypertension (DynAMITE Trial)

N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Must not have
Chronic thrombo-embolic pulmonary hypertension (CTEPH, WHO group 4)
Pulmonary hypertension with unclear and/or multi-factorial mechanisms (WHO group 5)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is evaluating the accuracy of data collected by the Walk.Talk.Track. app on the Apple Watch during a six-minute walk test.

Who is the study for?
This trial is for individuals diagnosed with WHO Group I Pulmonary Arterial Hypertension, including idiopathic, heritable forms and PAH associated with other conditions. Participants must be able to perform a 6-minute walk test and not have pulmonary hypertension due to heart disease, chronic lung disease, CTEPH, or unclear causes.
What is being tested?
The study tests the accuracy of an app-based 6-minute walk test (WTT) using an Apple Watch in both clinic and home settings. It aims to see if this method can reliably measure exercise capacity and monitor changes after starting treatment in newly diagnosed patients.
What are the potential side effects?
Since the intervention involves only monitoring physical activity through an app and watch without any drugs or invasive procedures involved, there are no direct side effects from the technology itself.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with chronic blood clot-related lung high blood pressure.
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I have high blood pressure in the lungs with unclear causes.
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I cannot complete a 6-minute walk test.
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I have high blood pressure in my lungs due to long-term lung disease.
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I have high blood pressure in my lungs due to heart disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
App/watch recorded and in-clinic recorded six minute walk distance (6MWD)
Count of participants with an increase of >32 meters in 6MWD from baseline as a measure of time to response to therapy
Heart rate
Secondary study objectives
Between group difference in 6MWD as a measure of response to the intervention
Count of participants with a decrease of >5bpm in resting HR from baseline as a measure of time to response to therapy
Count of participants with an increase of >5% in chronotropic index (CI) from baseline as a measure of time to response to therapy
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Initiating a new PAH medicationExperimental Treatment1 Intervention
Participants will start a new PAH medication
Group II: Continuing previous PAH medication regimenActive Control1 Intervention
Participants will continue the medication regimen that they were on prior to enrollment

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,467 Previous Clinical Trials
17,496,039 Total Patients Enrolled
5 Trials studying Pulmonary Arterial Hypertension
149 Patients Enrolled for Pulmonary Arterial Hypertension
PHawareUNKNOWN
~7 spots leftby Jun 2025
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