Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

Study Overview
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Brief Summary
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Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)

Detailed Description
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The study will evaluate the daily physical activity with the use of activity monitor, heart rate monitor and event monitor in patients with dilated cardiomyopathy (DCM). These wearables track the heart rate, heart rhythm, tracks activity and step count. The VO2 peak will be measured via the exercise test.

Official Title
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A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients

Conditions
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Dilated Cardiomyopathy

Intervention / Treatment
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* Device: Cardea SOLO
* Device: ActiGraph wGT3X-BT
* Device: Wavelet Wristband


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, 18-75 years of age Diagnosis of dilated cardiomyopathy (Unexplained left ventricular enlargement (left ventricular end diastolic dimension (LVEDD) >95th percentile for gender and height by echo or MRI) (Left ventricular ejection fraction (LVEF) less than 50%) CPET within 14 days prior to baseline visit with no intervening change in therapy Echocardiogram or cardiac MRI within 1 year prior to baseline Able to walk >100ft without limitation More than 30 minutes of exercise per week for at least 3 months prior to study enrollment, and plan to continue exercising for the next two weeks (duration of study). Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up) Exclusion Criteria: Heart failure hospitalization within four weeks prior to enrollment Non-cardiac limitation of activity 4. Prior exercise-induced syncope or exercise-induced sudden death 5. Primary exercise mode is swimming or stationary biking 6. Participation in competitive or high intensity exercise against medical advice 7. Implantable Cardiverter Defibrillator (ICD) placement in the 2 months prior to enrollment 8. Plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: All participants enrolled in the study will receive the wearables and will be evaluated for the relationship between daily physical activity levels and functional capacity (VO2 peak).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard<br>All participants will perform the CPET at Baseline visit and will be provided with the Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband. The participants will be asked to response to KCCQ and Stanford 7 day recall surveys. | Device: Cardea SOLO<br>* Participants will be asked to wear everyday for 7 days after the Baseline visit. the monitor attaches to the skin with adhesive and records heart rate and heart rhythm.<br>Device: ActiGraph wGT3X-BT<br>* Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable tracks activity and the step count during the day.<br>Device: Wavelet Wristband<br>* Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable measures the activity and the heart rate as measured by PPG sensor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2max correlation with daily physical activity | Maximal exercise capacity as measured by Max VO2 via CPET correlation with wearable device measures of daily physical activity | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA correlation with daily step count | Correlation between NYHA score and daily step count or maximal walking speed | 2 weeks | 
| KCCQ correlation with daily step count | Correlation between KCCQ score and daily step count or maximal walking speed | 2 weeks |