Pulmonary Arterial HypertensionDynAMITENCT03893500

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

A study testing Home-based 6 minute walk test in people with Pulmonary Arterial Hypertension, run by Stanford University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Pulmonary Arterial Hypertension
What is being tested?: Home-based 6 minute walk test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 1 Jul 2020to 1 Jun 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

Stanford University
Stanford, California, 94305

Other trials in United States

About this study

Official title: Utility of Device and App-based Mobile Health Monitoring as a Tool for Evaluation of Clinical Response to Therapies in Pulmonary Arterial Hypertension

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.

Conditions: Pulmonary Arterial Hypertension
Being tested: Home-based 6 minute walk test
Keywords: Six minute walk test, Six minute walk distance, Heart rate recovery, Mobile health
Medical subject headings: Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Home-based 6 minute walk testDevice
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.

Study groups in NCT03893500
Study group	Role	What they receive
Initiating an apple Watch	Experimental	Participants will start a new PAH medication Receives: Device: Home-based 6 minute walk test

What is being measured

The primary outcome is the main question the study is designed to answer.

App/Watch Recorded In-clinic Six Minute Walk Distance (6MWD)
Participants will be asked to walk as far as possible along a corridor for a period of six minutes.
Measured: 12 weeks

Secondary outcomes (1)

App/Watch Recorded In-clinic Steps
App/watch combined recorded and in-clinic recorded step count
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20201 Jun 2024

First posted28 Mar 2019
Study start1 Jul 2020
Primary completion1 Jun 2024
Study completion1 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (17)Papers the sponsor has linked to this study.
Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
More trials run by Stanford UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03893500
Sponsor's protocol ID: SU-DynAMITE
Other IDs: IRB-48742
Acronym: DynAMITE
Status last verified: Jun 2026
First submitted: 26 Mar 2019
Last updated: 28 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hoeper MM, Kramer T, Pan Z, Eichstaedt CA, Spiesshoefer J, Benjamin N, Olsson KM, Meyer K, Vizza CD, Vonk-Noordegraaf A, Distler O, Opitz C, Gibbs JSR, Delcroix M, Ghofrani HA, Huscher D, Pittrow D, Rosenkranz S, Grunig E. Mortality in pulmonary arterial hypertension: prediction by the 2015 European pulmonary hypertension guidelines risk stratification model. Eur Respir J. 2017 Aug 3;50(2):1700740. doi: 10.1183/13993003.00740-2017. Print 2017 Aug.
PubMed 28775047
Weatherald J, Boucly A, Sahay S, Humbert M, Sitbon O. The Low-Risk Profile in Pulmonary Arterial Hypertension. Time for a Paradigm Shift to Goal-oriented Clinical Trial Endpoints? Am J Respir Crit Care Med. 2018 Apr 1;197(7):860-868. doi: 10.1164/rccm.201709-1840PP. No abstract available.
PubMed 29256625
Wallen MP, Gomersall SR, Keating SE, Wisloff U, Coombes JS. Accuracy of Heart Rate Watches: Implications for Weight Management. PLoS One. 2016 May 27;11(5):e0154420. doi: 10.1371/journal.pone.0154420. eCollection 2016.
PubMed 27232714
Nogic J, Thein PM, Cameron J, Mirzaee S, Ihdayhid A, Nasis A. The utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: a randomised controlled trial protocol. BMC Cardiovasc Disord. 2017 Dec 29;17(1):303. doi: 10.1186/s12872-017-0726-8.
PubMed 29284402
Zoller D, Siaplaouras J, Apitz A, Bride P, Kaestner M, Latus H, Schranz D, Apitz C. Home Exercise Training in Children and Adolescents with Pulmonary Arterial Hypertension: A Pilot Study. Pediatr Cardiol. 2017 Jan;38(1):191-198. doi: 10.1007/s00246-016-1501-9. Epub 2016 Nov 14.
PubMed 27841007
Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.
PubMed 10536127
Tonelli AR, Wang XF, Alkukhun L, Zhang Q, Dweik RA, Minai OA. Heart rate slopes during 6-min walk test in pulmonary arterial hypertension, other lung diseases, and healthy controls. Physiol Rep. 2014 Jun 11;2(6):e12038. doi: 10.14814/phy2.12038. Print 2014 Jun 1.
PubMed 24920122
Swigris JJ, Olson AL, Shlobin OA, Ahmad S, Brown KK, Nathan SD. Heart rate recovery after six-minute walk test predicts pulmonary hypertension in patients with idiopathic pulmonary fibrosis. Respirology. 2011 Apr;16(3):439-45. doi: 10.1111/j.1440-1843.2010.01877.x.
PubMed 20946337
Ramos RP, Arakaki JS, Barbosa P, Treptow E, Valois FM, Ferreira EV, Nery LE, Neder JA. Heart rate recovery in pulmonary arterial hypertension: relationship with exercise capacity and prognosis. Am Heart J. 2012 Apr;163(4):580-8. doi: 10.1016/j.ahj.2012.01.023. Epub 2012 Mar 30.
PubMed 22520523
Dobre D, Zannad F, Keteyian SJ, Stevens SR, Rossignol P, Kitzman DW, Landzberg J, Howlett J, Kraus WE, Ellis SJ. Association between resting heart rate, chronotropic index, and long-term outcomes in patients with heart failure receiving beta-blocker therapy: data from the HF-ACTION trial. Eur Heart J. 2013 Aug;34(29):2271-80. doi: 10.1093/eurheartj/ehs433. Epub 2013 Jan 12.
PubMed 23315907
Huang RY, Dung LR. Measurement of heart rate variability using off-the-shelf smart phones. Biomed Eng Online. 2016 Jan 29;15:11. doi: 10.1186/s12938-016-0127-8.
PubMed 26822804
Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.
PubMed 9817683
Latus H, Bandorski D, Rink F, Tiede H, Siaplaouras J, Ghofrani A, Seeger W, Schranz D, Apitz C. Heart Rate Variability is Related to Disease Severity in Children and Young Adults with Pulmonary Hypertension. Front Pediatr. 2015 Jul 7;3:63. doi: 10.3389/fped.2015.00063. eCollection 2015.
PubMed 26217650
Azarbal B, Hayes SW, Lewin HC, Hachamovitch R, Cohen I, Berman DS. 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: superiority over 85% of maximal age-predicted heart rate. J Am Coll Cardiol. 2004 Jul 21;44(2):423-30. doi: 10.1016/j.jacc.2004.02.060.
PubMed 15261942
Provencher S, Chemla D, Herve P, Sitbon O, Humbert M, Simonneau G. Heart rate responses during the 6-minute walk test in pulmonary arterial hypertension. Eur Respir J. 2006 Jan;27(1):114-20. doi: 10.1183/09031936.06.00042705.
PubMed 16387943

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Arterial Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utility of Device and App-based Mobile Health Monitoring as a Tool for Evaluation of Clinical Response to Therapies in Pulmonary Arterial Hypertension
ClinicalTrials.gov ID: NCT03893500
Acronym / sponsor ID: DynAMITE / SU-DynAMITE
Conditions: Pulmonary Arterial Hypertension
Keywords: Six minute walk test, Six minute walk distance, Heart rate recovery, Mobile health
Study type: Interventional
Recruitment status: Completed
Enrolment: 63 participants (actual)
Lead sponsor: Stanford UniversityUniversity, hospital or other
Collaborators: PHaware
Study start: 1 Jul 2020 (actual)
Primary completion: 1 Jun 2024 (actual)
Study completion: 1 Jun 2024 (actual)
First posted: 28 Mar 2019 (actual)
Results: Posted 28 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Initiating an apple Watch	Experimental	Device: Home-based 6 minute walk testParticipants will start a new PAH medication

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Home-based 6 minute walk testParticipants 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.	Device	Initiating an apple Watch

Primary outcome

App/Watch Recorded In-clinic Six Minute Walk Distance (6MWD)
Time frame: 12 weeks
Participants will be asked to walk as far as possible along a corridor for a period of six minutes.

1 secondary outcome

App/Watch Recorded In-clinic Steps
Time frame: 12 weeks

Results and safety

Results posted to the registry on 28 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants	63	55

Primary outcome: App/Watch Recorded In-clinic Six Minute Walk Distance (6MWD)

Time frame: 12 weeks. Mean (Standard Deviation). Unit: meters

Measure	All Study Patients n = 55
Value	473 (32)

All Study Patients: Mean Difference (Net): 1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment to end of study (up to 1 year). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	0 of 55 (0%)	0 of 55 (0%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 28775047Hoeper MM, Kramer T, Pan Z, Eichstaedt CA, Spiesshoefer J, Benjamin N, Olsson KM, Meyer K, Vizza CD, Vonk-Noordegraaf A, Distler O, Opitz C, Gibbs JSR, Delcroix M, Ghofrani HA, Huscher D, Pittrow D, Rosenkranz S, Grunig E. Mortality in pulmonary arterial hypertension: prediction by the 2015 European pulmonary hypertension guidelines risk stratification model. Eur Respir J. 2017 Aug 3;50(2):1700740. doi: 10.1183/13993003.00740-2017. Print 2017 Aug.
Background: PubMed 29256625Weatherald J, Boucly A, Sahay S, Humbert M, Sitbon O. The Low-Risk Profile in Pulmonary Arterial Hypertension. Time for a Paradigm Shift to Goal-oriented Clinical Trial Endpoints? Am J Respir Crit Care Med. 2018 Apr 1;197(7):860-868. doi: 10.1164/rccm.201709-1840PP. No abstract available.
Background: PubMed 27232714Wallen MP, Gomersall SR, Keating SE, Wisloff U, Coombes JS. Accuracy of Heart Rate Watches: Implications for Weight Management. PLoS One. 2016 May 27;11(5):e0154420. doi: 10.1371/journal.pone.0154420. eCollection 2016.
Background: PubMed 29284402Nogic J, Thein PM, Cameron J, Mirzaee S, Ihdayhid A, Nasis A. The utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: a randomised controlled trial protocol. BMC Cardiovasc Disord. 2017 Dec 29;17(1):303. doi: 10.1186/s12872-017-0726-8.
Background: PubMed 27841007Zoller D, Siaplaouras J, Apitz A, Bride P, Kaestner M, Latus H, Schranz D, Apitz C. Home Exercise Training in Children and Adolescents with Pulmonary Arterial Hypertension: A Pilot Study. Pediatr Cardiol. 2017 Jan;38(1):191-198. doi: 10.1007/s00246-016-1501-9. Epub 2016 Nov 14.
Background: PubMed 10536127Cole CR, Blackstone EH, Pashkow FJ, Snader CE, Lauer MS. Heart-rate recovery immediately after exercise as a predictor of mortality. N Engl J Med. 1999 Oct 28;341(18):1351-7. doi: 10.1056/NEJM199910283411804.
Background: PubMed 24920122Tonelli AR, Wang XF, Alkukhun L, Zhang Q, Dweik RA, Minai OA. Heart rate slopes during 6-min walk test in pulmonary arterial hypertension, other lung diseases, and healthy controls. Physiol Rep. 2014 Jun 11;2(6):e12038. doi: 10.14814/phy2.12038. Print 2014 Jun 1.
Background: PubMed 20946337Swigris JJ, Olson AL, Shlobin OA, Ahmad S, Brown KK, Nathan SD. Heart rate recovery after six-minute walk test predicts pulmonary hypertension in patients with idiopathic pulmonary fibrosis. Respirology. 2011 Apr;16(3):439-45. doi: 10.1111/j.1440-1843.2010.01877.x.
Background: PubMed 22520523Ramos RP, Arakaki JS, Barbosa P, Treptow E, Valois FM, Ferreira EV, Nery LE, Neder JA. Heart rate recovery in pulmonary arterial hypertension: relationship with exercise capacity and prognosis. Am Heart J. 2012 Apr;163(4):580-8. doi: 10.1016/j.ahj.2012.01.023. Epub 2012 Mar 30.
Background: PubMed 23315907Dobre D, Zannad F, Keteyian SJ, Stevens SR, Rossignol P, Kitzman DW, Landzberg J, Howlett J, Kraus WE, Ellis SJ. Association between resting heart rate, chronotropic index, and long-term outcomes in patients with heart failure receiving beta-blocker therapy: data from the HF-ACTION trial. Eur Heart J. 2013 Aug;34(29):2271-80. doi: 10.1093/eurheartj/ehs433. Epub 2013 Jan 12.
Background: PubMed 26822804Huang RY, Dung LR. Measurement of heart rate variability using off-the-shelf smart phones. Biomed Eng Online. 2016 Jan 29;15:11. doi: 10.1186/s12938-016-0127-8.
Background: PubMed 9817683Enright PL, Sherrill DL. Reference equations for the six-minute walk in healthy adults. Am J Respir Crit Care Med. 1998 Nov;158(5 Pt 1):1384-7. doi: 10.1164/ajrccm.158.5.9710086.
ATS guidelines for the 6 minute walk testLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Home-based 6 minute walk test in people with Pulmonary Arterial Hypertension, run by Stanford University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

App/Watch Recorded In-clinic Six Minute Walk Distance (6MWD) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03893500, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.