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Home-based 6 minute walk test for Pulmonary Arterial 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

DynAMITE Trial 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.

Eligible Conditions

Pulmonary Arterial Hypertension

DynAMITE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

DynAMITE 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home-based 6 minute walk test

2020

N/A

~70

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Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,395 Previous Clinical Trials

17,341,292 Total Patients Enrolled

5 Trials studying Pulmonary Arterial Hypertension

149 Patients Enrolled for Pulmonary Arterial Hypertension

PHawareUNKNOWN

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity to take part in this research project?

"In order to gain entry into this trial, applicants must have been diagnosed with pulmonary arterial hypertension and be within the age range of 18-70 years. A total of 80 participants are needed for the experiment to proceed."

Answered by AI

What are the end goals of this clinical investigation?

"This medical trial's principal aim will be observed over 12 weeks and is to measure the six minute walk distance (6MWD). Additionally, researchers are investigating whether there is a difference between medication responders vs non-responders in terms of chronotropic index (CI), heart rate recovery at one minute (HRR1) and heart rate variability (HRV). Hazard ratios will then be computed every two weeks to detect any discrepancies."

Answered by AI

Are there vacancies for participants in this medical experiment?

"According to the information on clinicaltrials.gov, this study is not presently accepting participants. Initially posted in July of 2020 and most recently updated in August 2022, it does not appear that recruitment is actively underway at this time; yet there are still 749 trials searching for patients currently."

Answered by AI

Is this experiment accepting volunteers aged 75 or younger?

"To be considered for this experiment, potential participants must fall between the age range of 18 to 70. There are 54 trials available for minors and 662 studies open to seniors."

Answered by AI

Recent research and studies

CardiologyJournal

Heart Rate Response to a Timed Walk and Cardiovascular Outcomes in Older Adults: The Cardiovascular Health Study

Girotra, Saket, Dalane W. Kitzman, Willem J. Kop, Phyllis K. Stein, John S. Gottdiener, and Kenneth J. Mukamal. 2012. “Heart Rate Response to a Timed Walk and Cardiovascular Outcomes in Older Adults: The Cardiovascular Health Study”. Cardiology. S. Karger AG. doi:10.1159/000338736.

Journal of the American College of CardiologyJournal

The Incremental Prognostic Value of Percentage of Heart Rate Reserve Achieved over Myocardial Perfusion Single-photon Emission Computed Tomography in the Prediction of Cardiac Death and All-cause Mortality

Azarbal, Babak, Sean W. Hayes, Howard C. Lewin, Rory Hachamovitch, Ishac Cohen, and Daniel S. Berman. 2004. “The Incremental Prognostic Value of Percentage of Heart Rate Reserve Achieved over Myocardial Perfusion Single-photon Emission Computed Tomography in the Prediction of Cardiac Death and All-cause Mortality”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2004.02.060.

Plos OneJournal

Accuracy of Heart Rate Watches: Implications for Weight Management

Wallen, Matthew P., Sjaan R. Gomersall, Shelley E. Keating, Ulrik Wisløff, and Jeff S. Coombes. 2016. “Accuracy of Heart Rate Watches: Implications for Weight Management”. Edited by Jose A. L. Calbet. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0154420.

European Respiratory JournalJournal