Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy (MESA-DCM)
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|ClinicalTrials.gov Identifier: NCT03207230|
Recruitment Status : Withdrawn (Funding not secured)
First Posted : July 2, 2017
Last Update Posted : August 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Dilated Cardiomyopathy||Device: Cardea SOLO Device: ActiGraph wGT3X-BT Device: Wavelet Wristband||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention 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)|
|Official Title:||A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients|
|Estimated Study Start Date :||August 2017|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
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
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.
Device: ActiGraph wGT3X-BT
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.
Device: Wavelet Wristband
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.
- VO2max correlation with daily physical activity [ Time Frame: 2 weeks ]Maximal exercise capacity as measured by Max VO2 via CPET correlation with wearable device measures of daily physical activity
- NYHA correlation with daily step count [ Time Frame: 2 weeks ]Correlation between NYHA score and daily step count or maximal walking speed
- KCCQ correlation with daily step count [ Time Frame: 2 weeks ]Correlation between KCCQ score and daily step count or maximal walking speed
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): NCT03207230
|Principal Investigator:||Matthew T Wheeler, MD PhD||Stanford University|