Multicenter Exploratory Study of Accelerometry in Dilated Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-31

Study Completion Date

2018-03-31

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)

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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.

Conditions

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Dilated Cardiomyopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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).

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard

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.

Group Type EXPERIMENTAL

Cardea SOLO

Intervention Type DEVICE

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.

ActiGraph wGT3X-BT

Intervention Type DEVICE

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.

Wavelet Wristband

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Males and females, 18-75 years of age
2. 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%)
3. CPET within 14 days prior to baseline visit with no intervening change in therapy
4. Echocardiogram or cardiac MRI within 1 year prior to baseline
5. Able to walk \>100ft without limitation
6. 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).
7. Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up)

Exclusion Criteria

1. Heart failure hospitalization within four weeks prior to enrollment
2. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No