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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03893500
Recruitment Status : Active, not recruiting
First Posted : March 28, 2019
Last Update Posted : January 31, 2022
Sponsor:
Collaborator:
PHaware
Information provided by (Responsible Party):
Roham T. Zamanian, Stanford University

Brief 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.

    • 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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Device: Home-based 6 minute walk test Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022


Arm Intervention/treatment
Experimental: Initiating a new PAH medication
Participants will start a new PAH medication
Device: Home-based 6 minute walk test
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.

Active Comparator: Continuing previous PAH medication regimen
Participants will continue the medication regimen that they were on prior to enrollment
Device: Home-based 6 minute walk test
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.




Primary Outcome Measures :
  1. App/watch recorded and in-clinic recorded six minute walk distance (6MWD) [ Time Frame: 12 weeks ]
    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

  2. Count of participants with an increase of >32 meters in 6MWD from baseline as a measure of time to response to therapy [ Time Frame: 12 weeks ]
    Hazard ratios will be calculated at two week intervals to evaluate for between group differences

  3. 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 [ Time Frame: 12 weeks ]
    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


Secondary Outcome Measures :
  1. Count of participants with a decrease of >5bpm in resting HR from baseline as a measure of time to response to therapy [ Time Frame: 12 weeks ]
    Hazard ratios will be calculated at two week intervals to evaluate for between group differences

  2. Count of participants with an increase of >5ms in heart rate variability (HRV) from baseline as a measure of time to response to therapy [ Time Frame: 12 weeks ]
    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

  3. Count of participants with an increase of >5% in chronotropic index (CI) from baseline as a measure of time to response to therapy [ Time Frame: 12 weeks ]
    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

  4. 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 [ Time Frame: 12 weeks ]
    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

  5. Within the treatment arm, count of participants with a decrease of >5bpm in resting HR from baseline when comparing medication responders vs non-responders [ Time Frame: 12 weeks ]
    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

  6. 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 [ Time Frame: 12 weeks ]
    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

  7. 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 [ Time Frame: 12 weeks ]
    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

  8. Between group difference in 6MWD as a measure of response to the intervention [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03893500


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
PHaware
Additional Information:
Publications:

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Responsible Party: Roham T. Zamanian, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03893500    
Other Study ID Numbers: SU-DynAMITE
IRB-48742 ( Other Identifier: Administrative Panel on Human Subjects in Medical Research )
First Posted: March 28, 2019    Key Record Dates
Last Update Posted: January 31, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Roham T. Zamanian, Stanford University:
Six minute walk test
Six minute walk distance
Heart rate recovery
Mobile health
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases