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| ID | Type | Description | Link |
|---|---|---|---|
| IRB-48742 | Other Identifier | Administrative Panel on Human Subjects in Medical Research |
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| Name | Class |
|---|---|
| PHaware | UNKNOWN |
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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.
Prospectively monitor for changes in WTT app recorded 6MWT results following initiation of therapy in a treatment naïve cohort of PAH participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initiating a new PAH medication | Experimental | Participants will start a new PAH medication |
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| Continuing previous PAH medication regimen | Active Comparator | Participants will continue the medication regimen that they were on prior to enrollment |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Home-based 6 minute walk test | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| App/watch recorded and in-clinic recorded six minute walk distance (6MWD) | App/watch recorded and in-clinic recorded 6MWD will be compared by Bland Altman graph and will be considered interchangeable if the line of equality lands within the 95% confidence interval of the mean difference | 12 weeks |
| Count of participants with an increase of >32 meters in 6MWD from baseline as a measure of time to response to therapy | Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline as a measure of time to response to therapy | HRR1 is calculated as peak heart rate (pHR) - HR one minute into recovery period. Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Count of participants with a decrease of >5bpm in resting HR from baseline as a measure of time to response to therapy | Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Count of participants with an increase of >5ms in heart rate variability (HRV) from baseline as a measure of time to response to therapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28775047 | Background | 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. | |
| 29256625 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2026 | Jun 25, 2026 | 7 | ||
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000070857 | Walk Test |
| ID | Term |
|---|---|
| D005080 | Exercise Test |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
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|
HRV will be calculated as the standard deviation of R wave to R wave intervals (SDNN) over the 2 minute period following exercise. Hazard ratios will be calculated at two week intervals to evaluate for between group differences |
| 12 weeks |
| Count of participants with an increase of >5% in chronotropic index (CI) from baseline as a measure of time to response to therapy | CI will be calculated as (actual peak HR - resting HR)/(Age predicted peak HR [220-age] - resting HR). Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Within the treatment arm, count of participants with an increase of >3bpm in heart rate recovery at one minute (HRR1) from baseline when comparing medication responders vs non-responders | Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Within the treatment arm, count of participants with a decrease of >5bpm in resting HR from baseline when comparing medication responders vs non-responders | Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Within the treatment arm, count of participants with an increase of >5ms in heart rate variability (HRV) from baseline when comparing medication responders vs non-responders | Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Within the treatment arm, count of participants with an increase of >5% in chronotropic index (CI) from baseline when comparing medication responders vs non-responders | Medication responders will have a ≥32m improvement in 6MWD at 12 weeks; non-responders will have <32m improvement. Hazard ratios will be calculated at two week intervals to evaluate for between group differences | 12 weeks |
| Between group difference in 6MWD as a measure of response to the intervention | A two-sample T-test will be performed on the delta change in 6MWD (week 12 - baseline / baseline) x100]) between the treatment and control groups and a p-value will be calculated from this data. | 12 weeks |
| Background |
| 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. |
| 27232714 | Background | 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. |
| 29284402 | Background | 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. |
| 27841007 | Background | 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. |
| 10536127 | Background | 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. |
| 24920122 | Background | 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. |
| 20946337 | Background | 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. |
| 22520523 | Background | 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. |
| 23315907 | Background | 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. |
| 26822804 | Background | 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. |
| 9817683 | Background | 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. |
| 26217650 | Background | 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. |
| 15261942 | Background | 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. |
| 16387943 | Background | 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. |
| 22722364 | Background | Girotra S, Kitzman DW, Kop WJ, Stein PK, Gottdiener JS, Mukamal KJ. Heart rate response to a timed walk and cardiovascular outcomes in older adults: the cardiovascular health study. Cardiology. 2012;122(2):69-75. doi: 10.1159/000338736. Epub 2012 Jun 20. |
| 10022108 | Background | Lauer MS, Francis GS, Okin PM, Pashkow FJ, Snader CE, Marwick TH. Impaired chronotropic response to exercise stress testing as a predictor of mortality. JAMA. 1999 Feb 10;281(6):524-9. doi: 10.1001/jama.281.6.524. |
| D003933 | Diagnosis |