At-home Monitoring of Exercise Capacity for Pulmonary Hypertension

(DynAMITE Trial)

Overseen By Ryan j Anderson, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Left heart disease, Chronic lung disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

63 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for specific guidance.

What data supports the effectiveness of the treatment Home-based 6 minute walk test for Pulmonary Hypertension?

Research suggests that exercise programs, including home walking, may improve heart function and quality of life for people with pulmonary arterial hypertension, a type of pulmonary hypertension. Although more studies are needed, these programs have been found to be safe and acceptable to participants. ^{1 2 3 4 5}

Is the at-home 6-minute walk test safe for people with pulmonary hypertension?

The studies reviewed did not report any safety concerns or adverse events during the 6-minute walk test for people with pulmonary hypertension, suggesting it is generally safe. ^{1 2 3 6 7}

How is the home-based 6-minute walk test treatment unique for pulmonary hypertension?

The home-based 6-minute walk test is unique because it allows patients to monitor their exercise capacity at home, providing a convenient and accessible way to assess their condition without needing to visit a clinic. This approach differs from traditional treatments that often require supervised exercise programs or medical interventions. ^{1 2 3 4 5}

What is the purpose of this trial?

* 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.

Eligibility Criteria

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.

Inclusion Criteria

Do not meet exclusion criteria

I have been diagnosed with a specific type of high blood pressure in the lungs.

Exclusion Criteria

I have high blood pressure in my lungs due to long-term lung disease.

I cannot complete a 6-minute walk test.

I have been diagnosed with chronic blood clot-related lung high blood pressure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Walk.Talk.Track. app and Apple Watch to monitor exercise capacity and heart rate during a 12-week period, with new or continued PAH medication

12 weeks

In-clinic visits and home-based monitoring

Follow-up

Participants are monitored for changes in 6-minute walk distance and heart rate recovery after treatment

4 weeks

Treatment Details

Interventions

• Home-based 6 minute walk test

Trial Overview 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.

Participant Groups

Group I: Initiating a new PAH medication Experimental Treatment 1 Intervention

Participants will start a new PAH medication

Group II: Continuing previous PAH medication regimen Active Control 1 Intervention

Participants will continue the medication regimen that they were on prior to enrollment

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

PHaware

Collaborator

Trials

1

Recruited

60+

Findings from Research

A 12-week pilot study involving 16 patients with pulmonary arterial hypertension (PAH) showed that outpatient exercise programs, including multidisciplinary rehabilitation and home walking, may improve hemodynamic function and quality of life.

The study found improvements in right ventricular function, pulmonary artery pressure, and muscle strength, indicating that exercise is feasible and safe for PAH patients, but further research is needed to confirm these benefits due to the small sample size.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The exercise in pulmonary arterial hypertension (ExPAH) study: A randomized controlled pilot of exercise training and multidisciplinary rehabilitation in pulmonary arterial hypertension. Chia, KSW., Shiner, CT., Brown, K., et al.[2022]

The incremental shuttle walking test effectively stratifies mortality risk in patients with pulmonary arterial hypertension (PAH), with a significant reduction in 1-year mortality observed as walking distance increases, from 32% at ≤30 meters to 1% at ≥430 meters.

This study analyzed data from 1,847 PAH patients and established specific distance thresholds for risk categorization, which can be integrated into existing risk assessment tools, demonstrating the test's potential as a simple and effective alternative to traditional maximal exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maximal Exercise Testing Using the Incremental Shuttle Walking Test Can Be Used to Risk-Stratify Patients with Pulmonary Arterial Hypertension. Lewis, RA., Billings, CG., Hurdman, JA., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prognostic significance of six-minute walk test in non-group 1 pulmonary hypertension. [2018]

2. Brazil pubmed.ncbi.nlm.nih.gov

Validation of a treadmill six-minute walk test protocol for the evaluation of patients with pulmonary arterial hypertension. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Comparison of 6-min walk test distance and cardiopulmonary exercise test performance in children with pulmonary hypertension. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The exercise in pulmonary arterial hypertension (ExPAH) study: A randomized controlled pilot of exercise training and multidisciplinary rehabilitation in pulmonary arterial hypertension. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Value of cardiopulmonary exercise testing in comparing cardio-pulmonary function among patients with three kinds of pulmonary artery hypertension]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Maximal Exercise Testing Using the Incremental Shuttle Walking Test Can Be Used to Risk-Stratify Patients with Pulmonary Arterial Hypertension. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Is there a learning effect when the 6-minute walk test is repeated in people with suspected pulmonary hypertension? [2022]